Medical Devices
FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process Gao ID: GAO-09-190 January 15, 2009The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective. Class III devices must generally obtain an approved PMA, but until FDA issues regulations requiring submission of PMAs, certain types of class III devices may be cleared via the 510(k) process. The FDA Amendments Act of 2007 mandated that GAO study the 510(k) process. GAO examined which premarket review process--510(k) or PMA--FDA used to review selected types of device submissions in fiscal years 2003 through 2007. GAO reviewed FDA data and regulations, and interviewed FDA officials.
In fiscal years 2003 through 2007, as part of its premarket review to determine whether devices should be permitted to be marketed in the United States, FDA: (1) reviewed 13,199 submissions for class I and II devices via the 510(k) process, clearing 11,935 (90 percent) of these submissions; (2) reviewed 342 submissions for class III devices through the 510(k) process, clearing 228 (67 percent) of these submissions; and (3) reviewed 217 original and 784 supplemental PMA submissions for class III devices and approved 78 percent and 85 percent, respectively, of these submissions. Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete. GAO found that in fiscal years 2003 through 2007 FDA cleared submissions for 24 types of class III devices through the 510(k) process. As of October 2008, 4 of these device types had been reclassified to class II, but 20 device types could still be cleared through the 510(k) process. FDA officials said that the agency is committed to issuing regulations either reclassifying or requiring PMAs for the class III devices currently allowed to receive clearance for marketing via the 510(k) process, but did not provide a time frame for doing so.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-190, Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
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Report to Congressional Addressees:
United States Government Accountability Office:
GAO:
January 2009:
Medical Devices:
FDA Should Take Steps to Ensure That High-Risk Device Types Are
Approved through the Most Stringent Premarket Review Process:
GAO-09-190:
GAO Highlights:
Highlights of GAO-09-190, a report to congressional addressees.
Why GAO Did This Study:
The Food and Drug Administration (FDA) within the Department of Health
and Human Services (HHS) is responsible for oversight of medical
devices sold in the United States. Regulations place devices into three
classes, with class III including those with the greatest risk to
patients. Unless exempt by regulation, new devices must clear FDA
premarket review via either the 510(k) premarket notification process,
which determines if a new device is substantially equivalent to another
legally marketed device, or the more stringent premarket approval (PMA)
process, which requires the manufacturer to supply evidence providing
reasonable assurance that the device is safe and effective. Class III
devices must generally obtain an approved PMA, but until FDA issues
regulations requiring submission of PMAs, certain types of class III
devices may be cleared via the 510(k) process. The FDA Amendments Act
of 2007 mandated that GAO study the 510(k) process. GAO examined which
premarket review process”510(k) or PMA”FDA used to review selected
types of device submissions in fiscal years 2003 through 2007. GAO
reviewed FDA data and regulations, and interviewed FDA officials.
What GAO Found:
In fiscal years 2003 through 2007, as part of its premarket review to
determine whether devices should be permitted to be marketed in the
United States, FDA:
* reviewed 13,199 submissions for class I and II devices via the 510(k)
process, clearing 11,935 (90 percent) of these submissions;
* reviewed 342 submissions for class III devices through the 510(k)
process, clearing 228 (67 percent) of these submissions; and;
* reviewed 217 original and 784 supplemental PMA submissions for class
III devices and approved 78 percent and 85 percent, respectively, of
these submissions.
Although Congress envisioned that class III devices would be approved
through the more stringent PMA process, and the Safe Medical Devices
Act of 1990 required that FDA either reclassify or establish a schedule
for requiring PMAs for class III device types, this process remains
incomplete. GAO found that in fiscal years 2003 through 2007 FDA
cleared submissions for 24 types of class III devices through the
510(k) process. As of October 2008, 4 of these device types had been
reclassified to class II, but 20 device types could still be cleared
through the 510(k) process. FDA officials said that the agency is
committed to issuing regulations either reclassifying or requiring PMAs
for the class III devices currently allowed to receive clearance for
marketing via the 510(k) process, but did not provide a time frame for
doing so.
Figure: Class III Device Submissions with FDA Review Decisions in
Fiscal Years 2003 through 2007, by FDA Review Process and Review
Decision:
[Refer to PDF for image]
This figure is a stacked vertical bar graph depicting the following
data:
FDA review process: 510(k);
Number of submissions cleared/approved: 228 (67%);
Number of submissions not cleared/not approved: 114;
Total number of submissions: 342.
FDA review process: Original PMA;
Number of submissions cleared/approved: 170 (78%);
Number of submissions not cleared/not approved: 47;
Total number of submissions: 217.
FDA review process: Supplemental PMA;
Number of submissions cleared/approved: 664 (85%);
Number of submissions not cleared/not approved: 120;
Total number of submissions: 784.
Source: GAO analysis of FDA data.
Notes: 510(k) includes traditional and abbreviated 510(k) submissions.
Supplemental PMA includes certain types of submissions for changes to
devices that were previously approved through the PMA process. Not
cleared/not approved includes 510(k) submissions that were denied or
other (e.g., withdrawn) and PMAs that were withdrawn or otherwise not
approved.
[End of figure]
What GAO Recommends:
GAO recommends that FDA expeditiously take steps to issue regulations
for class III device types currently allowed to enter the market via
the 510(k) process by requiring PMAs or reclassifying them to a lower
class. HHS agreed with GAO‘s recommendation.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-190]. For more
information, contact Marcia Crosse at (202) 512-7114 or
crossem@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
FDA Used the 510(k) Process to Review Class I and II Device
Submissions, and Used Both the 510(k) and PMA Processes to Review Class
III Device Submissions:
Relatively Few Class II and Class III 510(k) Submissions Had a New
Intended Use or New Technological Characteristics:
Conclusions:
Recommendation for Executive Action:
Agency Comments:
Appendix I: Scope and Methodology:
Appendix II: Third-Party Review of 510(k) Submissions:
Appendix III: FDA's Implementation of Safe Medical Devices Act
Provisions:
Appendix IV: Additional Information on 510(k) Submissions for Class III
Devices Reviewed by FDA:
Appendix V: FDA's 510(k) Decision-Making Process:
Appendix VI: Comments from the Department of Health and Human Services:
Appendix VII: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: FDA 510(k) and PMA Decisions by Class, Fiscal Years 2003
through 2007:
Table 2: FDA Review Decisions for 510(k) Submissions for Class I and
Class II Devices, by Fiscal Year (2003-2007):
Table 3: 510(k) Submissions for Class I and Class II Devices Cleared in
Fiscal Years 2003 through 2007:
Table 4: Number of Submissions for Class III Devices Cleared through
the 510(k) Process in Fiscal Years 2003 through 2007:
Table 5: Characteristics of Cleared 510(k) Submissions, Fiscal Years
2005 through 2007:
Table 6: Characteristics of 510(k) Submissions for Devices FDA
Determined NSE in Fiscal Years 2005 through 2007:
Table 7: Scope of File Review by 510(k) Submission Type, Review
Decision, and FDA Office or Center:
Table 8: Cases Reviewed, by Fiscal Year:
Table 9: Cases Reviewed, by Class and SE/NSE Determination:
Table 10: Third-Party Review 510(k) Submissions with FDA Decisions,
Fiscal Years 2003 through 2007:
Table 11: Third-Party Review 510(k) Submissions by Medical Specialty,
Fiscal Years 2003 through 2007:
Table 12: FDA Groupings and Time Frames for Implementation of SMDA
Provisions for Class III Device Types in 1994 and Status as of October
2008:
Table 13: FDA Review Decisions for Class III 510(k) Submissions by
Fiscal Year, Fiscal Years 2003 through 2007:
Table 14: Primary Medical Specialties of Class III 510(k) Submissions
Cleared in Fiscal Years 2003 through 2007:
Table 15: Device Types with Class III 510(k) Submissions Cleared in
Fiscal Years 2003 through 2007 and Their Status as of October 2008:
Figures:
Figure 1: Devices That Manufacturers Listed with FDA during Fiscal
Years 2003 through 2007, by Review Process and Device Class:
Figure 2: FDA's 510(k) Decision-Making Process:
Figure 3: Class III Device Submissions with FDA Review Decisions in
Fiscal Years 2003 through 2007, by FDA Review Process and Review
Decision:
Figure 4: Proportion of Cleared 510(k) Submissions for Class III
Devices Flagged as Implantable, Life Sustaining, or of Significant
Risk, Review Decisions Made in Fiscal Years 2003 through 2007:
Figure 5: Projected Percentages of 510(k) Submissions for Class II and
Class III Devices in Fiscal Years 2005 through 2007 Reaching Each Point
in FDA's Decision-Making Process:
Figure 6: 510(k) Submissions Cleared in Fiscal Years 2005 through 2007,
by Technological Characteristics:
Figure 7: Detailed Version of FDA's 510(k) Decision-Making Process:
Figure 8: Simplified Version of FDA's 510(k) Decision-Making Process:
Figure 9: Projected Percentages of 510(k) Submissions for Class II and
Class III Devices in Fiscal Years 2005 through 2007 Reaching Each Point
in FDA's Detailed Decision-Making Process:
Figure 10: Projected Percentages of 510(k) Submissions for Class II
Devices in Fiscal Years 2005 through 2007 Reaching Each Point in FDA's
Decision-Making Process:
Figure 11: Percentages of 510(k) Submissions for Class III Devices in
Fiscal Years 2005 through 2007 Reaching Each Point in FDA's Decision-
Making Process:
Abbreviations:
FDA: Food and Drug Administration:
FDCA: Federal Food, Drug, and Cosmetic Act:
HHS: Department of Health and Human Services:
NSE: not substantially equivalent:
PMA: premarket approval:
SE: substantially equivalent:
SMDA: Safe Medical Devices Act of 1990:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
January 15, 2009:
The Honorable Edward M. Kennedy:
Chairman:
The Honorable Michael B. Enzi:
Ranking Member:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Henry A. Waxman:
Chairman:
The Honorable Joe Barton:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Charles E. Grassley:
United States Senate:
The Honorable John D. Dingell:
House of Representatives:
The federal government, through the Food and Drug Administration (FDA)
within the Department of Health and Human Services (HHS), is
responsible for ensuring that medical devices sold in the United States
provide reasonable assurance of safety and effectiveness and do not
pose a threat to public health.[Footnote 1] These devices range from
simple tools like bandages and surgical clamps to complicated devices
like pacemakers.
FDA classifies each device type into one of three classes--class I, II,
or III--based on the level of risk it poses and the controls necessary
to reasonably ensure its safety and effectiveness.[Footnote 2]
According to FDA, the risk the type of device poses to the patient or
the user is a major factor in the class it is assigned: class I
includes devices with the lowest risk, and class III includes devices
with the highest risk. Examples of types of devices in each class
include the following:
* class I: tongue depressors, elastic bandages, reading glasses, and
forceps;
* class II: electrocardiographs, powered bone drills, and mercury
thermometers; and:
* class III: pacemakers and replacement heart valves.
In general, unless exempt under FDA regulations, devices are subject to
one of two types of FDA premarket review before they may be legally
marketed in the United States.[Footnote 3]
* Premarket approval (PMA): The manufacturer must provide evidence,
typically including clinical data, providing reasonable assurance that
the new device is safe and effective. The PMA process is the most
stringent type of premarket review. A successful submission results in
FDA approval.
* Premarket notification (510(k)): The manufacturer must demonstrate to
FDA that the new device is substantially equivalent to a device already
legally on the market that does not require a PMA.[Footnote 4] A
successful submission results in FDA clearance.[Footnote 5]
In general, class I and II device types subject to premarket review are
required to obtain FDA clearance through the 510(k) process, and class
III device types are required to obtain FDA approval through the more
stringent PMA process. However, certain types of class III devices that
were in commercial distribution in the United States before May 28,
1976[Footnote 6] (called preamendment device types) and those
determined to be substantially equivalent to them may be cleared
through the less stringent 510(k) process until FDA publishes
regulations requiring them to go through the PMA process or
reclassifies them into a lower class.[Footnote 7] The Safe Medical
Devices Act of 1990 (SMDA) required FDA (1) to reexamine the
preamendment class III device types for which PMAs were not yet
required to determine if they should be reclassified to class I or II
or remain in class III and (2) to establish a schedule to promulgate
regulations requiring those preamendment device types that remain in
class III to obtain FDA approval through the PMA process.[Footnote 8]
Accordingly, all class III devices are eventually to be reviewed
through the PMA process.
The FDA Amendments Act of 2007[Footnote 9] mandated that GAO study
FDA's premarket review of devices under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (FDCA).[Footnote 10] This report discusses
(1) the premarket review process--510(k) or PMA--FDA used to review
class I, II, and III device submissions in fiscal years 2003 through
2007 and (2) the extent to which FDA has determined that devices
reviewed through the 510(k) process had new intended uses or new
technological characteristics.
To determine the premarket review process FDA used to review class I,
II, and III device submissions, as well as the number of submissions
reviewed and cleared in fiscal years 2003 through 2007, we obtained and
analyzed data from FDA's 510(k) and PMA databases. These databases
contain information on 510(k) and PMA submissions,[Footnote 11]
respectively, including the name of the device, the FDA-assigned
product code,[Footnote 12] the status of the submission, and any FDA
decisions related to the submission and the dates of those decisions.
We also used data from FDA's Device Nomenclature Management System to
determine other attributes of the device types covered by the 510(k)
and PMA submissions. We obtained and analyzed data on submissions for
which FDA made review decisions in fiscal years 2003 through 2007.
[Footnote 13] Our analysis included traditional and abbreviated 510(k)
submissions, original PMA submissions, and submissions for certain
types of PMA supplements (panel-track and 180-day user-fee
supplements).[Footnote 14] To assess the reliability of these data, we
interviewed FDA officials knowledgeable about these databases,
performed electronic testing for accuracy and completeness, and where
applicable compared our results to aggregate information from other
sources, such as published FDA reports and the FDA Web site. We
determined that the data were sufficiently reliable for the purposes of
this report.[Footnote 15]
To examine the extent to which FDA has determined that devices reviewed
through the 510(k) process had new intended uses or new technological
characteristics, we used FDA's 510(k) database to select and review all
class III 510(k) submission files and a stratified random sample of
class II 510(k) submission files for which FDA reached a determination
of substantially equivalent (SE) or not substantially equivalent (NSE)
in fiscal years 2005 through 2007. The sample totaled 459 submissions
to the Office of Device Evaluation within FDA's Center for Devices and
Radiological Health and did not include submissions to other FDA
offices or centers.[Footnote 16] In each case, we collected data
primarily from the FDA reviewer's memo, which outlined the decisions
that FDA made to reach its determination and summarized FDA's rationale
for finding the submission SE or NSE. Because our sample of class II
device submissions is representative of all class II device submissions
meeting our selection criteria, in reporting the results of our
analysis we provide estimates for the universe of all 4,900 traditional
and abbreviated 510(k) submissions for class II devices for which FDA
made determinations of SE or NSE in fiscal years 2005 through 2007. To
assess the reliability of the data we obtained from FDA's files, we
compared our results with information from FDA's 510(k) database. In
addition, we discussed cases where the determination path or rationale
was unclear with knowledgeable FDA officials. We determined that the
data were sufficiently reliable for the purposes of this report.
In addition to our data analysis, we reviewed relevant laws,
regulations, and FDA guidance, and interviewed FDA officials,
representatives of professional associations representing device
manufacturers, and consumer advocates. We conducted this performance
audit from March 2008 to January 2009 in accordance with generally
accepted government auditing standards. Those standards require that we
plan and perform the audit to obtain sufficient, appropriate evidence
to provide a reasonable basis for our findings and conclusions based on
our audit objectives. We believe that the evidence obtained provides a
reasonable basis for our findings and conclusions based on our audit
objectives.
Results in Brief:
In fiscal years 2003 through 2007, FDA reviewed all class I and II
device submissions through the 510(k) process, and reviewed some types
of class III device submissions through the 510(k) process and others
through the PMA process.
* FDA reviewed all 13,199 submissions for class I and class II devices
through the 510(k) process, clearing 90 percent (11,935 submissions)
for marketing.
* FDA reviewed 342 submissions for class III devices through the 510(k)
process, clearing 67 percent (228 submissions) for marketing.
* FDA also reviewed 217 original PMA submissions and 784 supplemental
PMA submissions for class III devices, approving 78 percent and 85
percent, respectively, of these submissions for marketing.
Although Congress envisioned that class III devices would be approved
through the more stringent PMA process, and the SMDA required that FDA
establish a schedule for doing so, this process remains incomplete. We
found that in the 5-year period we examined FDA cleared submissions for
24 class III device types through the 510(k) process. These submissions
were more likely than class I or class II submissions to be implantable
or life sustaining, or to pose a significant risk to the health,
safety, or welfare of a patient. As of October 2008, 4 of the 24 device
types had been reclassified and 20 class III device types could still
be cleared through the 510(k) process. FDA officials have acknowledged
the importance of publishing regulations requiring PMA submissions or
reclassifying preamendment class III device types. When asked for their
time frame for doing so, however, the officials did not provide one.
In fiscal years 2005 through 2007, FDA determined that relatively few
class II and III devices reviewed through the 510(k) process had a new
intended use or new technological characteristics. Of the 5,063 class
II or class III 510(k) submissions with SE or NSE determinations in
this time period, we estimate that about 1 percent had a new intended
use and about 15 percent had new technological characteristics. Among
devices FDA determined SE (and therefore cleared for marketing), all of
the submissions had the same intended use and 86 percent had the same
technological characteristics as a device already on the market. In
contrast, among the 248 510(k) submissions found NSE, FDA determined
that more than half of the devices had a new intended use or new
technological characteristics.
We are recommending that FDA expeditiously take steps to issue
regulations for each class III device type currently allowed to enter
the market through the 510(k) process, including (1) reclassifying each
device type into a lower class or requiring it to remain in class III
and (2) for those device types remaining in class III, requiring
approval for marketing through the PMA process. HHS commented that the
draft report fairly and accurately describes the FDA's medical device
510(k) program and the department agreed with our conclusions and
recommendation.
Background:
The Medical Device Amendments of 1976 established three classes of
medical devices.[Footnote 17] Under current law, these three device
classes are defined as follows:
* Class I devices are those for which compliance with general controls,
such as good manufacturing practices specified in FDA's quality system
regulation, are sufficient to provide reasonable assurance of their
safety and effectiveness.
* Class II devices are subject to general controls and may also be
subject to special controls, such as postmarket surveillance, patient
registries, or specific FDA guidelines, if general controls alone are
insufficient to provide reasonable assurance of the device's safety and
effectiveness.[Footnote 18]
* Class III devices are subject to general controls, but are
distinguished from class I and II devices because class III devices are
those (1) for which insufficient information exists to determine
whether general and special controls are sufficient to provide a
reasonable assurance of the safety and effectiveness of the device and
(2) that support or sustain human life or are of substantial importance
in preventing impairment of human health, or that present a potential
unreasonable risk of illness or injury.
Devices Exempt from FDA Premarket Review:
Under federal regulations, many types of devices are exempt from FDA
premarket review.[Footnote 19] Although FDA does not track the number
of devices that are actually sold or marketed in the United States,
manufacturers are required to register with FDA and provide a list of
devices intended for commercial distribution, including device types
that are exempt from premarket review.[Footnote 20] As shown in figure
1, about 67 percent of the more than 50,000 separate devices that
manufacturers listed with FDA during fiscal years 2003 through 2007
were exempt from premarket review.[Footnote 21] Of the exempt devices
that manufacturers listed with FDA, about 95 percent were class I
devices, for example reading glasses and forceps. About 5 percent were
class II devices, for example wheeled stretchers and mercury
thermometers.
Figure 1: Devices That Manufacturers Listed with FDA during Fiscal
Years 2003 through 2007, by Review Process and Device Class:
[Refer to PDF for image]
This figure contains a pie-chart and a subset pie-chart depicting the
following data:
Devices That Manufacturers Listed with FDA during Fiscal Years 2003
through 2007, by Review Process and Device Class:
Exempt: 67%; (Class I: 95%; Class II: 5%);
510(k): 31%;
PMA: 1%;
Other[A]: 1%.
Source: GAO analysis of FDA data.
Notes: Data are for the 50,189 devices listed with FDA by device
manufacturers during the period October 1, 2002, through September 30,
2007. Even if their devices are exempt from premarket notification
requirements, manufacturers must still comply with other FDA
requirements, such as good manufacturing practice requirements
specified in FDA's quality system regulation. See 21 C.F.R. pt. 820
(2008).
[A] Other includes devices that were allowed to enter the market via
other means, such as through the humanitarian device exemption process
that allows market entry, without adherence to certain requirements,
for devices benefiting patients with rare diseases or conditions.
[End of figure]
Premarket Review Process for Class III Devices:
With the enactment of the Medical Device Amendments of 1976, Congress
imposed requirements under which all class III devices would be
approved through the PMA process before being marketed in the United
States.[Footnote 22] However, when it passed the 1976 amendments,
Congress distinguished between those devices in commercial distribution
before the date of enactment and those entering the market on or after
enactment.
* Preamendment devices. Class III devices that were in commercial
distribution prior to May 28, 1976 (referred to as preamendment
devices) were allowed to be reviewed and cleared for the U.S. market
without PMA approval until FDA published final regulations requiring
each device type to obtain approval for the U.S. market through the PMA
process.[Footnote 23]
* Postamendment devices. Devices that were not in commercial
distribution prior to May 28, 1976 (referred to as postamendment
devices) were classified automatically into class III and required to
go through the PMA process unless FDA either (1) determined they were
substantially equivalent to a preamendment device type for which
premarket approval is not required[Footnote 24] or (2) reclassified the
device type into class I or class II.[Footnote 25]
Within this framework, Congress thus envisioned that class III devices
would be approved through the more stringent PMA process and that the
premarket review of class I and class II devices would entail a lesser
degree of scrutiny.
By the late 1980s, FDA had not acted to require PMAs for many
preamendment class III device types.[Footnote 26] In 1990, the SMDA
required FDA to:
1. before December 1, 1995, order industry submission of safety and
effectiveness information for preamendment class III device types that
were not yet required to go through the PMA process;
2. after ordering industry submission of safety and effectiveness
information but before December 1, 1995, publish regulations for each
such device either revising its classification into class I or class II
or requiring it to remain in class III;[Footnote 27] and:
3. as promptly as is reasonably achievable, but not later than 12
months after the effective date of a regulation requiring a device to
remain in class III, establish a schedule for the promulgation of
regulations requiring the submission of PMAs for the preamendment class
III device types required to remain in class III.[Footnote 28]
The House of Representatives report accompanying the SMDA stated that
"In formulating these schedules, the FDA should take into account its
priorities and limited resources, together with the Committee's
intention that the evaluation process be expeditious."[Footnote 29]
In May 1994, FDA published a notice in the Federal Register announcing
a strategy for implementation of the SMDA.[Footnote 30] According to
the FDA memorandum outlining this strategy, the agency planned the
following:
* To publish proposed regulations by 1996 requiring PMAs for 15 device
types that FDA had determined to present an unreasonably high risk to
public health because significant issues of safety or effectiveness or
both were not being resolved or, to the best of FDA's knowledge, had
little probability of being resolved. According to FDA, the timetable
for publication of each final regulation would be based on specific
data needs, comments received (in response to the proposed rule), and
the existence, if any, of petitions received to reclassify the devices.
* To order manufacturers to submit information on safety and
effectiveness by 1998 for 58 device types. FDA identified 27 of these
device types as not presenting as great a risk to the public health in
light of FDA's knowledge and experience with the devices. FDA
identified the other 31 device types as strong candidates for
reclassification. FDA's strategy stated that after receipt of the
safety and effectiveness information, the agency would proceed with
rule making to either reclassify the devices or retain them in class
III.
* To issue one proposed regulation in 1994 requiring PMAs for 44 device
types in limited use.
The agency's strategy established a plan to start addressing the class
III device types that were allowed to go through the 510(k) process,
but it did not establish completion dates for doing so. See appendix
III for additional information on the FDA strategy.
FDA's 510(k) Review Process:
As a general rule, devices are subject to 510(k) premarket review
unless exempt or required to go through the PMA process. Specifically,
the 510(k) process, established in 1976, requires a device manufacturer
to notify FDA 90 days before it intends to market a device and to
establish that the device is substantially equivalent to a legally
marketed device that does not require a PMA. The legally marketed
device is referred to as a predicate device. Under federal regulations,
a predicate device can be a device that:
* was legally marketed prior to May 28, 1976, for which a PMA is not
required; or:
* was marketed on or after May 28, 1976, and was found to be
substantially equivalent to a legally marketed device through the
510(k) process; or:
* was reclassified by FDA from class III to class II or I.[Footnote 31]
FDA reviews each 510(k) submission to determine whether the device in
question is SE or NSE to a predicate device.[Footnote 32] To be SE, a
device must (1) have the same intended use as the predicate device and
(2) have the same technological characteristics as the predicate device
or have different technological characteristics and submitted
information demonstrates that the device is as safe and effective as
the marketed device and does not raise different questions of safety or
effectiveness. Because the predicate device may be a device that was
marketed on or after May 28, 1976, that was found SE when compared to
another legally marketed device through the 510(k) process, there could
be multiple iterations of a given device type cleared through the
510(k) process. As a result, a 510(k) submission for a new device in
2008 could be compared to the 20th iteration of a device type that was
on the market before 1976. Figure 2 shows FDA's 510(k) decision-making
process.
Figure 2: FDA's 510(k) Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the FDA's 510(k) decision-making
process, as follows:
1) New device is compared to a predicate device:
2) Does the new device have the same intended use?
If yes: go to step 3;
If no: Not Substantially Equivalent (NSE).
3) Does the new device have the same technological characteristics?
If yes: go to step 5;
If no: go to step 4.
4) Do the new technological characteristics raise new types of safety
or effectiveness questions?[A]
If yes: Not Substantially Equivalent (NSE);
If no: go to step 5.
5) Do descriptive or performance data demonstrate equivalence?
If yes: Substantially Equivalent (NSE);
If no: Not Substantially Equivalent (NSE).
Source: GAO.
Notes: In cases where FDA determines that a new device has new
technological characteristics that could not affect safety and
effectiveness, the device may be determined SE if descriptive
characteristics alone are precise enough to ensure equivalence. In
cases where FDA determines that a new device has new technological
characteristics that could affect safety and effectiveness, FDA
requires performance data to demonstrate substantial equivalence. For
cases in which descriptive or performance information is insufficient,
FDA requests additional information.
[A] For devices with new technological characteristics, FDA first
examines whether the new technological characteristics could affect
safety or effectiveness.
[End of figure]
Relative to the PMA process, the 510(k) premarket review process is
generally:
* Less stringent. For most 510(k) submissions, clinical data are not
required and substantial equivalence will normally be determined based
on comparative device descriptions, including performance data.
[Footnote 33] In contrast, in order to meet the PMA approval
requirement of providing reasonable assurance that a new device is safe
and effective, most original PMAs and some PMA supplements require
clinical data.[Footnote 34] In addition, other aspects of FDA's
premarket review are less stringent for 510(k) submissions than for PMA
submissions. For example, FDA generally does not inspect manufacturing
establishments as part of the 510(k) premarket review process--the
510(k) review process focuses primarily on the end product of the
manufacturing process rather than the manufacturing process itself. In
contrast, the agency does inspect manufacturing establishments as part
of its review of original PMA submissions.[Footnote 35] Manufacturing
establishments that produce devices cleared through the 510(k) process,
as well as those that produce devices approved through the PMA process,
are subject to periodic inspections under FDA's normal inspection
program.[Footnote 36]
* Faster. FDA generally makes decisions on 510(k) submissions faster
than it makes decisions on PMA submissions. FDA's fiscal year 2009 goal
is to review and decide on 90 percent of 510(k) submissions within 90
days and 98 percent of them within 150 days. The comparable goal for
PMAs is to review and decide upon 60 percent of original PMA
submissions in 180 days and 90 percent of them within 295 days.
[Footnote 37]
* Less expensive. The estimated cost to FDA for reviewing submissions
is substantially lower for 510(k) submissions than for PMA submissions.
For fiscal year 2005, for example, according to FDA the estimated
average cost for the agency to review a 510(k) submission was about
$18,200, while the estimate for a PMA submission was about $870,000.
For the applicant, the standard fee provided to FDA at the time of
submission is also significantly lower for a 510(k) submission than for
a PMA submission. In fiscal year 2009, for example, the standard fee
for 510(k) submissions is $3,693, while the standard fee for original
PMA submissions is $200,725.[Footnote 38]
Consumer advocates have raised questions regarding the number of
devices, particularly class III devices, that are cleared through the
510(k) process and regarding the use of the 510(k) process to clear
devices that may utilize new technologies that are different than those
in the marketed devices to which they are compared. Officials of
associations representing medical device manufacturers, however, have
asserted that the 510(k) premarket review is an important tool for
reviewing device submissions, saying that it is a rigorous process that
gives FDA the flexibility to identify and request the information it
needs to assess the safety and effectiveness of medical devices.
FDA Used the 510(k) Process to Review Class I and II Device
Submissions, and Used Both the 510(k) and PMA Processes to Review Class
III Device Submissions:
In fiscal years 2003 through 2007, FDA reviewed all submissions for
class I and II devices through the 510(k) process, and reviewed
submissions for some types of class III devices through the 510(k)
process and others through the PMA process. Specifically, FDA reviewed
all 13,199 submissions for class I and class II devices through the
510(k) process, clearing 11,935 (90 percent) of these submissions. FDA
also reviewed 342 submissions for class III devices through the 510(k)
process, clearing 228 (67 percent) of these submissions. In addition,
the agency reviewed 217 original PMA submissions and 784 supplemental
PMA submissions for class III devices and approved 78 percent and 85
percent, respectively, of these submissions. Although Congress
envisioned that class III devices would be approved through the more
stringent PMA process, we found that FDA has not published regulations
requiring PMA submissions for some types of preamendment class III
devices nor has it reclassified them. As a result, some types of class
III devices have been cleared for the U.S. market through the 510(k)
process.
Table 1 summarizes the FDA review decisions, by class of device, in
fiscal years 2003 through 2007 for 510(k) and PMA submissions.
Table 1: FDA 510(k) and PMA Decisions by Class, Fiscal Years 2003
through 2007:
Submission type: 510(k);
Device class: Class I;
SE or approved (percentage of row): 1,265 (84);
NSE or denied (percentage of row): 40 (3);
Other decision[A](percentage of row): 204 (14);
Total (percentage of row): 1,509 (100).
Submission type: 510(k);
Device class: Class II;
SE or approved (percentage of row): Submission type: 10,670 (91);
NSE or denied (percentage of row): Submission type: 373 (3);
Other decision[A](percentage of row): Submission type: 647 (6);
Total (percentage of row): Submission type: 11,690 (100).
Submission type: 510(k);
Device class: Class III;
SE or approved (percentage of row): Submission type: 228 (67);
NSE or denied (percentage of row): Submission type: 100 (29);
Other decision[A](percentage of row): Submission type: 14 (4);
Total (percentage of row): Submission type: 342 (100).
Submission type: 510(k);
Device class: Other[B];
SE or approved (percentage of row): Submission type: 476 (33);
NSE or denied (percentage of row): Submission type: 27 (2);
Other decision[A](percentage of row): Submission type: 955 (66);
Total (percentage of row): Submission type: 1,458 (100).
Submission type: PMA; Original;
Device class: Class III;
SE or approved (percentage of row): 170 (78);
NSE or denied (percentage of row): [C];
Other decision[A](percentage of row): 47 (22)[C];
Total (percentage of row): 217 (100).
Submission type: PMA; Supplemental[D];
Device class: Class III;
SE or approved (percentage of row): 664 (85);
NSE or denied (percentage of row): [C];
Other decision[A](percentage of row): 120 (15)[C];
Total (percentage of row): 784 (100).
Source: GAO analysis of FDA data.
Notes: Data represent 14,999 traditional and abbreviated 510(k)
submissions, 217 original PMA submissions, and 784 supplemental PMA
submissions for which FDA made review decisions in fiscal years 2003
through 2007. Percentages may not sum to 100 because of rounding.
[A] Other decisions include submissions that were withdrawn, were
exempted by regulation, were not responsive to FDA's requests within a
specified time frame, were forwarded to another FDA center (e.g., drugs
or biologics), were duplicates, or were for products determined not to
be devices.
[B] Other device class includes submissions for which a device class
was not recorded in FDA's 510(k) database.
[C] According to FDA data, all PMA decisions during fiscal years 2003
through 2007 were approved or withdrawn. FDA did not deny approval of
any PMA submissions during this period. According to FDA officials,
when a PMA was seriously deficient, FDA issued a "not approvable"
letter under 21 C.F.R. § 814.44(f) and placed the submission on hold. A
company may withdraw a submission voluntarily. FDA also considers
submissions to be withdrawn voluntarily if the applicant is unable to
provide the information necessary to support approval within 180 days.
[D] Supplemental PMA submissions include 180-day (user-fee) and panel-
track PMA supplements. The numbers in this row do not include other
types of PMA supplements.
[End of table]
FDA Reviewed All Submissions for Class I and Class II Devices through
the 510(k) Process:
FDA reviewed all class I and class II device submissions in fiscal
years 2003 through 2007 through the 510(k) process. As shown in table
2, FDA cleared approximately 9 out of every 10 of the 510(k)
submissions for class I and class II devices for which FDA made review
decisions during this time period.
Table 2: FDA Review Decisions for 510(k) Submissions for Class I and
Class II Devices, by Fiscal Year (2003-2007):
Fiscal year: 2003;
FDA decision: SE (percentage of row): 2,519 (90);
FDA decision: NSE (percentage of row): 72 (3);
FDA decision: Other decision[A](percentage of row): 215 (8);
Total (percentage of row): 2,806 (100).
Fiscal year: 2004;
FDA decision: SE (percentage of row): 2,484 (92);
FDA decision: NSE (percentage of row): 86 (3);
FDA decision: Other decision[A](percentage of row): 119 (4);
Total (percentage of row): 2,689 (100).
Fiscal year: 2005;
FDA decision: SE (percentage of row): 2,395 (90);
FDA decision: NSE (percentage of row): 89 (3);
FDA decision: Other decision[A](percentage of row): 164 (6);
Total (percentage of row): 2,648 (100).
Fiscal year: 2006;
FDA decision: SE (percentage of row): 2,325 (91);
FDA decision: NSE (percentage of row): 78 (3);
FDA decision: Other decision[A](percentage of row): 156 (6);
Total (percentage of row): 2,559 (100).
Fiscal year: 2007;
FDA decision: SE (percentage of row): 2,212 (89);
FDA decision: NSE (percentage of row): 88 (4);
FDA decision: Other decision[A](percentage of row): 197 (8);
Total (percentage of row): 2,497 (100).
Fiscal year: Total;
FDA decision: SE (percentage of row): 11,935 (90);
FDA decision: NSE (percentage of row): 413 (3);
FDA decision: Other decision[A](percentage of row): 851 (6);
Total (percentage of row): 13,199 (100).
Source: GAO analysis of FDA data.
Note: Percentages may not sum to 100 because of rounding.
[A] Other decisions include submissions that were withdrawn, exempted
by regulation, not responsive to FDA's requests within a specified time
frame, forwarded to another FDA center or office, duplicates, or for
products determined not to be devices or not actively regulated by FDA.
[End of table]
Of the 10,670 510(k) submissions for class II devices that FDA cleared
in fiscal years 2003 through 2007, FDA's databases identified one-
quarter as being for devices that were implantable; were life
sustaining; or presented significant risk to the health, safety, or
welfare of a patient (see table 3). Of these characteristics,
implantable was the most frequently identified characteristic. In terms
of 510(k) submissions for class I devices, according to FDA, none of
the more than 1,200 510(k) submissions for class I devices that FDA
cleared during the same time period were for devices that were
implantable; were life sustaining; or presented significant risk to the
health, safety, or welfare of a patient.
Table 3: 510(k) Submissions for Class I and Class II Devices Cleared in
Fiscal Years 2003 through 2007:
Class I:
Flag: Implantable only (percentage of row): 0 (0);
Flag: Life sustaining only (percentage of row): 0 (0);
Flag: Significant risk only (percentage of row): 0 (0);
Flag: More than one flag (percentage of row): 0 (0);
No flag (percentage of row): 1,265 (100);
Total (percentage of row): 1,265 (100).
Class II:
Flag: Implantable only (percentage of row): 1,957 (18);
Flag: Life sustaining only (percentage of row): 266 (3);
Flag: Significant risk only (percentage of row): 159 (1);
Flag: More than one flag (percentage of row): 235 (2);
No flag (percentage of row): 8,053 (75);
Total (percentage of row): 10,670 (100).
Total:
Flag: Implantable only (percentage of row): 1,957 (16);
Flag: Life sustaining only (percentage of row): 266 (2);
Flag: Significant risk only (percentage of row): 159 (1);
Flag: More than one flag (percentage of row): 235 (2);
No flag (percentage of row): 9,318 (78);
Total (percentage of row): 11,935 (100).
Source: GAO analysis of FDA data.
Note: Percentages may not sum to 100 because of rounding.
[End of table]
FDA Reviewed Submissions for Some Class III Devices Types through the
510(k) Process and Others through the PMA Process:
In fiscal years 2003 through 2007, FDA reviewed submissions for some
types of class III devices through the 510(k) process, and other types
of class III devices through the PMA process. Specifically, FDA
reviewed 342 submissions for new class III devices through the 510(k)
process, determining 228 (67 percent) of these submissions to be SE to
a predicate device.[Footnote 39] During the same time period, FDA
reviewed 217 original PMA submissions and 784 supplemental PMA
submissions for class III devices and approved 78 percent and 85
percent of them, respectively. (See figure 3.)
Figure 3: Class III Device Submissions with FDA Review Decisions in
Fiscal Years 2003 through 2007, by FDA Review Process and Review
Decision:
[Refer to PDF for image]
This figure is a stacked vertical bar graph depicting the following
data:
FDA review process: 510(k);
Number of submissions cleared/approved: 228 (67%);
Number of submissions not cleared/not approved: 114;
Total number of submissions: 342.
FDA review process: Original PMA;
Number of submissions cleared/approved: 170 (78%);
Number of submissions not cleared/not approved: 47;
Total number of submissions: 217.
FDA review process: Supplemental PMA;
Number of submissions cleared/approved: 664 (85%);
Number of submissions not cleared/not approved: 120;
Total number of submissions: 784.
Source: GAO analysis of FDA data.
Notes: Figure represents FDA review decisions made between October 1,
2002, and September 30, 2007, for class III device submissions reviewed
through the 510(k) and PMA processes. 510(k) includes traditional and
abbreviated 510(k) submissions; supplemental PMA includes panel-track
supplements and 180-day (user-fee) supplements.
Not cleared/not approved includes (1) for 510(k) submissions, those
submissions FDA found to be NSE or withdrawn and (2) for PMA
submissions, those submissions that were withdrawn. According to FDA
data, all PMA decisions during fiscal years 2003 through 2007 were
approved or withdrawn. FDA did not deny approval of any PMA submissions
during this period. According to FDA officials, when a PMA is seriously
deficient, FDA issues a "not approvable" letter and places the
submission on hold. An applicant may then withdraw a submission
voluntarily. FDA also considers submissions to be withdrawn voluntarily
if the applicant is unable to provide the information necessary to
support approval within 180 days.
[End of figure]
FDA Has Not Issued Regulations Requiring PMA Submissions for Some Types
of Class III Devices:
Although Congress envisioned that class III devices would be approved
through the more stringent PMA process, and the SMDA required that FDA
establish a schedule for doing so, this process remains incomplete. The
228 class III submissions that FDA cleared through the 510(k) process
in fiscal years 2003 through 2007 were allowed to undergo premarket
review through the 510(k) process because they were for preamendment
class III device types, or those substantially equivalent to them, for
which FDA had not yet issued regulations either requiring PMA
submissions or reclassifying them. These 228 510(k) submissions
involved 24 device types (see table 4).[Footnote 40] Of these types, 16
were included in one of the priority groups in FDA's 1994 strategy for
reclassifying or requiring PMAs for class III device types, and in
particular 4 device types--accounting for 39 of the 228 submissions--
were among those that FDA identified as presenting an unreasonably high
risk to public health.
Table 4: Number of Submissions for Class III Devices Cleared through
the 510(k) Process in Fiscal Years 2003 through 2007:
Group: Included in a priority group in FDA's 1994 strategy;
Number of device types: 16;
Number of submissions cleared in FYs 2003-2007: 123;
Examples: Certain types of hip joints, implanted blood access devices.
Group: Other[A];
Number of device types: 8;
Number of submissions cleared in FYs 2003-2007: 105;
Examples: Pedicle screws for certain types of spinal surgeries, dental
implants, automated external defibrillator.
Group: Total;
Number of device types: 24;
Number of submissions cleared in FYs 2003-2007: 228.
Source: GAO analysis of FDA data.
[A] Other includes device types for which FDA had already taken some
action by 1994 (for example, FDA indicated that it had reclassification
petitions pending for some device types in 1994) as well as new device
types that FDA established after 1994 (for example, FDA issued a new
regulation for a subset of one device type).
[End of table]
The class III submissions FDA cleared through the 510(k) process were
more likely than other 510(k) submissions to be for device types that
were implantable; were life sustaining; or pose a significant risk to
the health, safety, or welfare of a patient. Of the 228 510(k)
submissions for class III devices that FDA cleared in fiscal years 2003
through 2007, FDA's databases flagged 66 percent as being for device
types that are implantable, life sustaining, or of significant risk
(see figure 4). This compares to no 510(k) submissions for class I
devices and 25 percent of 510(k) submissions for class II devices.
Figure 4: Proportion of Cleared 510(k) Submissions for Class III
Devices Flagged as Implantable, Life Sustaining, or of Significant
Risk, Review Decisions Made in Fiscal Years 2003 through 2007:
[Refer to PDF for image]
This figure contains a pie-chart and a subset pie-chart depicting the
following data:
Any Risk flagged: 66%;
- More than one flag: 51%;
- Implantable only: 41%;
- Significant risk only;
No risk flagged: 34%.
Actual numbers:
Any risk flagged: 150;
No risk flagged: 78;
Missing data: 0.
Implantable only: 62;
Life-sustaining only: 0;
Significant risk only: 12;
More than one flag: 76.
Source: GAO analysis of FDA data.
Notes: Figure represents data for 228 510(k) submissions for class III
devices that FDA determined to be SE in fiscal years 2003 through 2007.
FDA's database flagged 150 of these submissions as device types that
were implantable; were life sustaining; presented significant risk to
the health, safety, or welfare of a patient; or a combination of those
flags.
[End of figure]
Four of the 24 class III device types for which FDA cleared 510(k)
submissions in fiscal years 2003 through 2007 have since been
reclassified by FDA as class II device types.[Footnote 41] Twenty of
the 24 device types, however, may still be cleared through the 510(k)
process.[Footnote 42] Further, there are other preamendment class III
device types that did not happen to have any 510(k) submissions cleared
in fiscal years 2003 through 2007 that are also still eligible to be
cleared through the 510(k) process.
FDA officials have acknowledged the importance of publishing
regulations requiring PMA submissions or reclassifying preamendment
class III device types. When asked for their time frame for doing so,
the officials did not provide one. Rather, they responded that that the
agency is committed to addressing this issue as resources and
priorities permit.
Relatively Few Class II and Class III 510(k) Submissions Had a New
Intended Use or New Technological Characteristics:
In our review of 510(k) submission files for which FDA reached a
determination of SE or NSE in fiscal years 2005 through 2007, we found
that FDA determined that relatively few devices had a new intended use
or new technological characteristics. Overall, we found that FDA
determined about 1 percent of class II and III submissions had a new
intended use and about 15 percent had new technological
characteristics.[Footnote 43] For the 510(k) submissions that FDA
cleared, FDA found that all of the devices had the same intended use as
their predicate devices, and 86 percent also had the same technological
characteristics. In contrast, of the 510(k) submissions that FDA
determined to be NSE, more than half were for devices that had a new
intended use or new technological characteristics.
Figure 5 shows the estimated percentage of 510(k) submissions reaching
each step in the review process. See appendix V for additional
information on FDA's decision-making process.
Figure 5: Projected Percentages of 510(k) Submissions for Class II and
Class III Devices in Fiscal Years 2005 through 2007 Reaching Each Point
in FDA's Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the Projected Percentages of 510(k)
Submissions for Class II and Class III Devices in Fiscal Years 2005
through 2007 Reaching Each Point in FDA's Decision-Making Process, as
follows:
Number: 5,062.
1) New device is compared to a predicate device:
2) Does the new device have the same intended use?
If yes: go to step 3 (98.5% yes);
If no: Not Substantially Equivalent (NSE) (0.7% had a new intended
use).
3) Does the new device have the same technological characteristics?
If yes: go to step 6 (83.2% yes);
If no: go to step 4 (15.4% has new technological characteristics).
4) Do the new technological characteristics raise new types of safety
or effectiveness questions?[A]
If yes: Not Substantially Equivalent (NSE) (0.5%);
If no: go to step 5 (14.9%).
5) Do descriptive or performance data demonstrate equivalence?
If yes: Substantially Equivalent (NSE) (13.6%);
If no: Not Substantially Equivalent (NSE) (1.3%).
6) Do descriptive or performance data demonstrate equivalence?
If yes: Substantially Equivalent (NSE) (81.5%);
If no: Not Substantially Equivalent (NSE) (1.7%).
Total: Substantially Equivalent (NSE): 95.1%;
Total: Not Substantially Equivalent (NSE): 4.9%[B].
Source: GAO.
Notes: Estimates based on GAO review of all class III and a sample of
class II 510(k) submissions. This figure includes data for 510(k)
submissions for class II and class III devices that FDA determined to
be SE and NSE in fiscal years 2005 through 2007. The sampling errors of
the estimated percentages of 510(k) submissions reaching SE or NSE in
FDA's decision-making process are within plus or minus 1 percentage
point at the 95 percent confidence level.
In cases where FDA determines that a new device has new technological
characteristics that could not affect safety and effectiveness, the
device may be determined SE if descriptive characteristics alone are
precise enough to ensure equivalence. In cases where FDA determines
that a new device has new technological characteristics that could
affect safety and effectiveness, FDA requires performance data to
demonstrate substantial equivalence. For cases in which descriptive or
performance information is insufficient, FDA requests additional
information.
[A] For devices with new technological characteristics, FDA first
examines whether the new technological characteristics could affect
safety or effectiveness.
[B] Includes some submissions (0.6% of the 5,063 510(k) submissions) in
which FDA made a determination of NSE but for which the determination
path is not represented in this figure. Reasons that these cases were
found NSE include the applicant failing to respond to an FDA data
request and a PMA already being required for the device.
[End of figure]
All 510(k) Submissions That FDA Cleared Had the Same Intended Use and
Most Had the Same Technological Characteristics as Predicate Devices:
All 510(k) submissions for class II and class III devices that FDA
cleared in fiscal years 2005 through 2007 had the same intended use and
most had the same technological characteristics as predicate devices.
In all 4,815 class II and class III submissions cleared through the
510(k) process during this time period, FDA determined that the new
devices had the same intended use as their predicate devices. In 86
percent of these submissions, we found that FDA determined that the new
devices also had the same technological characteristics as their
predicate devices. (See figure 6.)
Figure 6: 510(k) Submissions Cleared in Fiscal Years 2005 through 2007,
by Technological Characteristics:
[Refer to PDF for image]
This figure is a pie-chart depicting the following data:
510(k) Submissions Cleared in Fiscal Years 2005 through 2007, by
Technological Characteristics:
Same technological characteristics: 86%;
New technological characteristics: 14%.
Source: GAO analysis of FDA files.
Notes: Data are estimated results for 4,815 submissions based on a
sample of submissions for class II and class III devices cleared by FDA
during fiscal years 2005 through 2007. The sampling errors of the
estimated percentages in this chart are within plus or minus 5
percentage points at the 95 percent confidence level.
[End of figure]
In 14 percent of the class II and class III submissions cleared through
the 510(k) process in fiscal years 2005 through 2007, FDA determined
that the new device had new technological characteristics. For the
cleared submissions with new technological characteristics, FDA
determined, among other things, that either:
1. the new technological characteristics could not affect safety or
effectiveness--for example, FDA determined that software modifications
to a defibrillator allowing physicians greater control over the
device's CPR (cardiopulmonary resuscitation) settings could not affect
the safety or effectiveness of the defibrillator--or:
2. the new characteristics do not raise new types of safety or
effectiveness questions--for example, FDA determined that a digital
electrocardiograph did not raise new types of effectiveness questions
relative to the predicate device, an analog electrocardiograph.
Table 5 shows the distribution of cleared submissions by class and
characteristics of the determination.
Table 5: Characteristics of Cleared 510(k) Submissions, Fiscal Years
2005 through 2007:
Characteristics of cleared submissions: Same technological
characteristics;
Class II (percentage): 4,052 (86%);
Class III (percentage): 75 (77%);
Total (percentage): 4,127 (86%).
Characteristics of cleared submissions: New technological
characteristics that could not affect safety or effectiveness;
Class II (percentage): 323 (7%);
Class III (percentage): 12 (12%);
Total (percentage): 335 (7%).
Characteristics of cleared submissions: New technological
characteristics that do not raise new types of safety or effectiveness
questions;
Class II (percentage): 342 (7%);
Class III (percentage): 11 (11%);
Total (percentage): 353 (7%).
Characteristics of cleared submissions: Total;
Class II (percentage): 4,717 (100%);
Class III (percentage): 98 (100%);
Total (percentage): 4,815 (100%).
Source: GAO analysis of FDA files.
Note: Data are estimated for 4,815 510(k) submissions based on a sample
of submissions for class II and class III devices cleared by FDA in
fiscal years 2005 through 2007. The sampling errors of the estimates of
class II 510(k) submissions and total 510(k) submissions are within
plus or minus 5 percentage points at the 95 percent confidence level.
[End of table]
More Than Half of the 510(k) Submissions FDA Determined Not
Substantially Equivalent Were for Devices That Had a New Intended Use
or New Technological Characteristics:
We found that of the 248 class II and III submissions that FDA
determined to be NSE in fiscal years 2005 through 2007, slightly more
than half:
* had a new intended use,
* had a new technological characteristic that raised new types of
safety or effectiveness questions, or:
* had a new technological characteristic that could affect safety or
effectiveness and did not have performance data to demonstrate
equivalence to the predicate device.
We also found that about one in every three 510(k) submissions FDA
determined to be NSE had the same intended use and the same
technological characteristics as the predicate device, but FDA
determined the submissions NSE because of a lack of performance data.
An additional 13 percent of submissions were determined NSE for other
reasons, such as not providing adequate data early in the review or not
having a predicate device (see table 6).
Table 6: Characteristics of 510(k) Submissions for Devices FDA
Determined NSE in Fiscal Years 2005 through 2007:
Characteristics: New intended use;
Class II (percentage): 15 (8);
Class III (percentage): 22 (34);
Total (percentage): 37 (15).
Characteristics: New technological characteristics that raise new types
of safety or effectiveness questions;
Class II (percentage): 19 (10);
Class III (percentage): 22 (34);
Total (percentage): 41 (17).
Characteristics: New technological characteristics and insufficient
performance data;
Class II (percentage): 42 (23);
Class III (percentage): 7 (11);
Total (percentage): 49 (20).
Characteristics: Same technological characteristics, but insufficient
performance data;
Class II (percentage): 88 (48%);
Class III (percentage): 1 (2%);
Total (percentage): 89 (36%).
Characteristics: Other[A];
Class II (percentage): 19 (10%);
Class III (percentage): 13 (20%);
Total (percentage): 32 (13%).
Characteristics: Total;
Class II (percentage): 183 (100%);
Class III (percentage): 65 (100%);
Total (percentage): 248 (100%).
Source: GAO analysis of FDA files.
Notes: Data are estimated for 248 510(k) submissions for class II and
class III devices that FDA determined NSE in fiscal years 2005 through
2007. The sampling errors of the estimates of class II 510(k)
submissions and total 510(k) submissions are within plus or minus 10
percentage points at the 95 percent confidence level.
Percentages may not add to 100 because of rounding.
[A] Other includes 510(k) submissions for devices that were required to
go through the PMA process, devices that did not have a predicate, and
those that were determined to be NSE because of a lack of data early in
the 510(k) process.
[End of table]
Conclusions:
The 510(k) process plays a major role in FDA's oversight of medical
devices. During fiscal years 2003 through 2007, FDA reviewed over 2,400
510(k) submissions annually and cleared about 90 percent of these
submissions for the U.S. market. These included 228 cleared submissions
for class III devices. In establishing device classes in 1976, Congress
envisioned that all class III devices would eventually be required to
undergo premarket review through the more stringent PMA process, which
requires the manufacturer to provide evidence, which may include
clinical data, providing reasonable assurance that the new device is
safe and effective. However, certain preamendment class III device
types may be reviewed through the 510(k) process until such time as FDA
publishes regulations requiring them to go through the PMA process. In
1990 the SMDA directed FDA to take action on the remaining preamendment
class III device types by reclassifying them to a lower class or
requiring them to remain in class III and go through the PMA process,
but we found that more than 14 years after FDA published its strategy
and plans for doing so, a significant number of class III devices--
including device types that FDA has identified as implantable; life
sustaining; or posing a significant risk to the health, safety, or
welfare of a patient--still enter the market through the less stringent
510(k) process.
FDA has stated that eventually all class III devices will require FDA
approval through the PMA process and FDA officials reported that the
agency is committed to addressing this issue, but the agency has not
specified time frames for doing so. Without FDA action, the remaining
preamendment class III device types--including device types that FDA
identified in 1994 as presenting an unreasonably high risk to public
health--may enter the U.S. market through FDA's less stringent
premarket notification process.
Recommendation for Executive Action:
We are recommending that the Secretary of Health and Human Services
direct the FDA Commissioner to expeditiously take steps to issue
regulations for each class III device type currently allowed to enter
the market through the 510(k) process. These steps should include
issuing regulations to (1) reclassify each device type into class I or
class II, or requiring it to remain in class III, and (2) for those
device types remaining in class III, require approval for marketing
through the PMA process.
Agency Comments:
We received comments on a draft of this report from HHS. (See appendix
VI.) The department commented that the draft report fairly and
accurately describes FDA's 510(k) program and the department agreed
with our conclusions and recommendation.
HHS agreed with our recommendation that FDA expeditiously take steps to
reclassify or require PMAs for each class III device type currently
allowed to enter the market through the 510(k) process, noting that
since 1994 (when FDA announced it strategy to implement provisions of
the Safe Medical Devices Act of 1990) FDA has called for PMAs or
reclassified the majority of class III devices that did not require
PMAs at that time. The department's comments, however, do not specify
time frames in which FDA will address the remaining class III device
types allowed to enter the market via the 510(k) process, stating
instead that the agency is considering its legal and procedural options
for completing this task as expeditiously as possible, consistent with
available resources and competing time frames. Given that more than 3
decades have passed since Congress envisioned that all class III
devices would eventually be required to undergo premarket review
through the more stringent PMA process, it is imperative that FDA take
immediate steps to address the remaining class III device types that
may still enter the market through the less stringent 510(k) process by
requiring PMAs for or reclassifying them.
The department also provided technical comments, which we incorporated
as appropriate.
We are sending copies of this report to the Secretary of Health and
Human Services and other interested parties. The report is also
available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix VII.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
To review the Food and Drug Administration's (FDA) use of the 510(k)
and premarket approval (PMA) processes to review class I, II, and III
device submissions in fiscal years 2003 through 2007, we used FDA's
510(k) and PMA databases. These databases contain information on device
submissions,[Footnote 44] including the name of the device, the FDA-
assigned product code,[Footnote 45] the status of the submission, and
any FDA decisions related to the submission and the dates of those
decisions. In both cases, we obtained and analyzed data on submissions
for which FDA made a review decision in fiscal years 2003 through 2007.
[Footnote 46] We also used FDA's Device Nomenclature Management System
to determine other attributes of the device types covered by the device
submissions.
The 510(k) submissions we analyzed included traditional and abbreviated
510(k) submissions. We did not include special 510(k) submissions,
which are requests for clearance of modifications to devices that have
already been cleared through the 510(k) process (see table 7). The PMA
submissions we analyzed included original PMA submissions and some
supplemental PMA submissions. Specifically, we included supplemental
PMA submissions that represented requests for approval for a
significant change in a device: panel-track supplements, which are
requests for approval for a significant change in design, performance,
or use of a device for which clinical data are necessary to provide a
reasonable assurance of safety and effectiveness; and 180-day (user-
fee) supplements, which are requests for approval for a significant
change in components, materials, design, specification, software, color
additives, or labeling. We did not include other types of PMA
supplements, such as real-time supplements, which are requests for
approval for a minor change to a device, such as a minor change in
design, sterilization, software, or labeling.[Footnote 47]
To assess the reliability of these data, we interviewed FDA officials
knowledgeable about these databases, performed electronic testing for
accuracy and completeness, and where applicable compared our results to
aggregate information from other sources, such as published FDA reports
and the FDA Web site. We determined that the data were sufficiently
reliable for the purposes of this report.
In order to examine the extent to which FDA has determined that devices
reviewed through the 510(k) process had new intended uses or new
technological characteristics, we used FDA's 510(k) database to select
and review a stratified random sample of class II and all class III
510(k) submission files from fiscal years 2005 through 2007. See table
7 for the scope of our file review.
Table 7: Scope of File Review by 510(k) Submission Type, Review
Decision, and FDA Office or Center:
Characteristic of 510(k) submission: Submission type: Traditional;
Included in file review? Yes;
Reason: Traditional 510(k) submissions are the conventional 510(k)
submission type used to clear new devices for market. Traditional
submissions constituted the majority of 510(k) submissions made to FDA
during the time of our review.
Characteristic of 510(k) submission: Submission type: Abbreviated;
Included in file review? Yes;
Reason: Abbreviated 510(k) submissions are a streamlined version of the
traditional 510(k) process. In an abbreviated 510(k) submission,
applicants use guidance documents, special controls, or performance
standards to assess and then report on the performance of their new
device to expedite review.
Characteristic of 510(k) submission: Submission type: Special;
Included in file review? No;
Reason: Special 510(k) submissions are submitted for a modification to
a device that has been cleared through the 510(k) process. We excluded
them from our review because this type of submission is only used for
modifications to a device which has already cleared the 510(k) process.
Characteristic of 510(k) submission: Review decision: Substantially
equivalent (SE);
Included in file review? Yes;
Reason: The submissions completed the 510(k) review process and were
cleared for market.
Characteristic of 510(k) submission: Review decision: Not substantially
equivalent (NSE);
Included in file review? Yes;
Reason: The submissions completed the 510(k) review process and were
not cleared for market.
Characteristic of 510(k) submission: Review decision: Withdrawn;
Included in file review? No;
Reason: Withdrawn submissions did not complete the 510(k) review
process.
Characteristic of 510(k) submission: Review decision: Deleted;
Included in file review? No;
Reason: Deleted submissions did not complete the 510(k) review process.
Characteristic of 510(k) submission: FDA office or center: Center for
Devices and Radiological Health, Office of Device Evaluation;
Included in file review? Yes;
Reason: This office administers the 510(k), PMA, Humanitarian Device
Exemption, and Investigational Device Exemption programs. It processes
the majority of 510(k) submissions each year: for example, in FY 2007,
it processed 85 percent of all 510(k) submissions.
Characteristic of 510(k) submission: FDA office or center: Center for
Devices and Radiological Health, Office of In Vitro Diagnostic Device
Evaluation and Safety;
Included in file review? No;
Reason: This office oversees the regulation of devices such as in-home
and laboratory diagnostic tests, and processes relatively few 510(k)
submissions each year. In FY 2007, it processed 13 percent of all
510(k) submissions.
Characteristic of 510(k) submission: FDA office or center: Center for
Biologics Evaluation and Research;
Included in file review? No;
Reason: This office oversees devices such as those used for licensed
blood collection and processing, and processes relatively few 510(k)
submissions each year. In FY 2007, it processed 2 percent of all 510(k)
submissions.
Source: GAO.
Note: The scope of the file review also excluded de novo submissions,
which are submissions for first-of-a-kind devices lacking a legally
marketed predicate. See 21 U.S.C. § 360c(f)(2).
[End of table]
All 163 class III submissions that met the inclusion criteria were
included in the sample. The 296 class II cases included in the sample
constituted a random sample of the 4,900 class II submissions that met
the inclusion criteria. The class II submissions included in the sample
were stratified by decision, meaning that class II submissions
determined not substantially equivalent (NSE) were oversampled so that
the results could be generalizable to the universe of all class II
submissions, to class II submissions determined NSE, or to class II
submissions determined substantially equivalent (SE). The sample
contained a total of 459 submissions. See tables 8 and 9 for the number
of submissions by fiscal year, class, and decision.
Table 8: Cases Reviewed, by Fiscal Year:
Fiscal year: 2005;
Count: 167;
Percentage: 36.
Fiscal year: 2006;
Count: 141;
Percentage: 31.
Fiscal year: 2007;
Count: 151;
Percentage: 33.
Fiscal year: Total;
Count: 459;
Percentage: 100.
Source: GAO.
[End of table]
Table 9: Cases Reviewed, by Class and SE/NSE Determination:
FDA decision: SE;
Class II: 195;
Class III: 102;
Total: 297.
FDA decision: NSE;
Class II: 101;
Class III: 61;
Total: 162.
FDA decision: Total;
Class II: 296;
Class III: 163;
Total: 459.
Source: GAO.
[End of table]
We conducted our file review in June 2008. We collected data primarily
from the FDA reviewer memo, which contained information concerning the
steps FDA took to reach its determination of SE or NSE. This
information included the incremental decisions FDA made concerning the
use and technological characteristics of the new device, and in sum,
defined the path through an FDA decision tree the reviewer took to
reach a determination of SE or NSE. See figures 7 and 8 for detailed
and simplified versions, respectively, of FDA's decision tree. We
recorded the individual decisions made in each case, and analyzed the
results with respect to the path the FDA reviewer took to reach the
final determination of SE or NSE.
Figure 7: Detailed Version of FDA's 510(k) Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the detailed version of FDA's 510(k)
decision-making process, as follows:
New device is compared to a predicate device:
[Descriptive information about new or marketed device requested as
needed]
1) Does the device have the same indication statement? [Box 1]
Yes: go to step 3;
No: go to step 2.
2) Do differences alter the intended effect of the device? [Box 1]
Yes: go to step 3;
No: go to step 4.
3) New device has new intended use:
Go to step 17.
4) New device has new intended use: Does the new device have the same
technological characteristics? [Box 2]
Yes: go to step 7;
No: go to step 5.
5) Could the new characteristics affect safety or effectiveness? [Box
3]
Yes: go to step 6;
No: go to step 10.
6) Do the new technological characteristics raise new types of safety
or effectiveness questions? [Box 3]
Yes: go to step 17;
No: go to step 13.
7) Are the descriptive characteristics precise enough to ensure
equivalence? [Box 5]
Yes: go to step 16;
No: go to step 8.
8) Are performance data available to assess equivalence?[A] [Box 5]
Yes: go to step 9;
9) Do performance data demonstrate equivalence? [Box 5]
Yes: go to step 16;
No: go to step 17.
10) Are the descriptive characteristics precise enough to ensure
equivalence? [Box 4]
Yes: go to step 16;
No: go to step 11.
11) Are performance data available to assess equivalence?[A] [Box 4]
Yes: go to step 12;
12) Do performance data demonstrate equivalence?
Yes: go to step 16;
No: go to step 17.
13) Do accepted scientific methods exist for assessing effects of the
new characteristics? [Box 3]
Yes: go to step 14;
No: go to step 17.
14) Are performance data available to assess effects of new
characteristics?[A] [Box 4]
Yes: go to step 15.
15) Do performance data demonstrate equivalence? [Box 4]
Yes: go to step 16;
No: go to step 17.
16) Substantially Equivalent (SE).
17) Not Substantially Equivalent (NSE).
Source: GAO.
Notes: Numbered boxes correspond to numbered boxes on the simplified
FDA decision-making process in figure 8.
[A] Data may be in the 510(k), other 510(k)s, the center‘s
classification files, or the literature. In cases where FDA determines
that performance data are not available, FDA requests data from the
applicant.
[End of figure]
Figure 8: Simplified Version of FDA's 510(k) Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the simplified version of FDA's
510(k) decision-making process, as follows:
New device is compared to a predicate device:
Box 1: Does the device have the same indication statement?
Yes: go to Box 2;
No: Not Substantially Equivalent (NSE).
Box 2: Does the new device have the same technological characteristics?
Yes: go to Box 5;
No: go to Box 3.
Box 3: Do the new technological characteristics raise new types of
safety or effectiveness questions?
Yes: Not Substantially Equivalent (NSE);
No: go to Box 4.
Box 4: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE);
No: Not Substantially Equivalent (NSE).
Box 5: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE);
No: Not Substantially Equivalent (NSE).
Source: GAO.
Notes: Numbered boxes correspond to numbered boxes on the detailed
decision tree in figure 7.
In cases where FDA determines that a new device has new technological
characteristics that could not affect safety and effectiveness, the
device may be determined SE if descriptive characteristics alone are
precise enough to ensure equivalence. If not, FDA will look at
performance data. In cases where FDA determines that a new device has
new technological characteristics that could affect safety and
effectiveness, FDA requires performance data to demonstrate substantial
equivalence. For cases in which descriptive or performance information
is insufficient, FDA requests additional information.
[A] For devices with new technological characteristics, FDA first
examines whether the new technological characteristics could affect
safety or effectiveness.
[End of figure]
In the 10 cases where we could not determine the steps FDA took to
reach its determination during our file review, we requested additional
information from FDA officials. Officials from the Office of Device
Evaluation in FDA's Center for Devices and Radiological Health reviewed
the files in question and provided us with the information we
requested.
To assess the reliability of these data, we compared our results with
information from FDA's 510(k) database and Device Nomenclature
Management System. In addition, FDA officials stated that the data in
the files were accurate and reliable and provided input in the
development of our data collection instrument.
In addition to our data analysis, we reviewed relevant laws and
regulations concerning the premarket review process. We also
interviewed FDA officials from the FDA centers and offices that process
device submissions (Center for Biologics Evaluation and Research,
Office of Device Evaluation, and Office of In Vitro Diagnostic Device
Evaluation and Safety). Finally, we interviewed representatives from
professional associations representing device manufacturers (the
Advanced Medical Technology Association, the ECRI Institute, the
Medical Device Manufacturers Association, and the Medical Imaging and
Technology Alliance) and consumer advocates (the National Research
Center for Women & Families and Public Citizen).
We conducted this performance audit from March 2008 to January 2009 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
[End of section]
Appendix II: Third-Party Review of 510(k) Submissions:
The FDA Modernization Act of 1997 directed FDA to accredit third
parties (called accredited persons) in the private sector to conduct
the initial review of 510(k) submissions for low-to moderate-risk
devices.[Footnote 48] Under FDA's Accredited Persons Program, device
manufacturers may contract with accredited organizations (third
parties)[Footnote 49] to review certain 510(k) submissions for a
negotiated fee.[Footnote 50] The third party uses the same statutory
and regulatory criteria as FDA to determine substantial equivalence,
documents its review and recommendation, and forwards the 510(k)
submission and documentation to FDA's Center for Devices and
Radiological Health. At the center, a third-party 510(k) submission is
assessed by an FDA supervisor, who may accept or change the substantial
equivalence recommendation of the third party. After completing the
supervisory assessment, FDA issues a letter to the 510(k) applicant via
the third-party reviewer with a final determination on the 510(k)
submission. During the third-party review, the FDA supervisor can
request additional information from the third party and the third party
can request additional information from the 510(k) applicant.
FDA expanded the program to include more than 670 class I and class II
device types to be eligible for 510(k) review by a third party.
[Footnote 51] These include device types for diagnostic ultrasound
systems, computed tomography X-ray systems, and surgical lasers.
However, not all of the accredited third parties are authorized to
review all device types eligible for third-party review. For example,
in October 2008 FDA's Web site listed 7 of 11 accredited third parties
as authorized to review 510(k) submissions for hearing aids.
Device types that are not eligible for third-party review include all
class III devices; class II devices intended to be permanently
implantable, life sustaining, or life supporting; and class II devices
requiring clinical data to support their 510(k) clearance.[Footnote 52]
During our review of FDA's 510(k) database, we found three instances of
510(k) submissions in which class II devices that were life sustaining
were cleared for market through the third-party review program during
fiscal years 2003 through 2007. FDA officials explained that about five
life-sustaining, class II device types, hemodialysis devices, had
inadvertently been added to the list of devices eligible for third-
party review when the list was expanded in 2001, and that in May 2003,
FDA removed the life-sustaining class II device types from the list of
devices eligible for third-party review on FDA's Web site. The FDA
officials said that while the three 510(k) submissions for class II
life-sustaining device submissions had been submitted through the third-
party review program, FDA also conducted its own review of the three
510(k) submissions before they were cleared for marketing.
During fiscal years 2003 through 2007, FDA reviewed and made final
determinations on 1,082 third-party 510(k) submissions (see table 10).
According to FDA, the number of third-party submissions increased as
the result of (1) increased familiarity with the third-party review
program among potential applicants, (2) the increase in the number of
device types eligible for the program, and (3) less financial
disincentives to use the third-party review program as FDA instituted
device user fees.[Footnote 53] An FDA official familiar with the
program stated that the third-party review program may be more
attractive to device manufacturers because third-party review 510(k)
submissions are processed faster than traditional 510(k) submissions.
The official noted, however, that as FDA's review of traditional 510(k)
submissions becomes more efficient, the advantages of the third-party
review program in terms of timeliness may diminish, which could lead to
fewer third-party review 510(k) submissions.[Footnote 54]
Table 10: Third-Party Review 510(k) Submissions with FDA Decisions,
Fiscal Years 2003 through 2007:
Fiscal year: 2003;
FDA decision: SE (percentage): 157 (15);
FDA decision: NSE (percentage): 2 (10);
Total (percentage): 159 (15).
Fiscal year: 2004;
FDA decision: SE (percentage): 227 (21);
FDA decision: NSE (percentage): 9 (43);
Total (percentage): 236 (22).
Fiscal year: 2005;
FDA decision: SE (percentage): 226 (21);
FDA decision: NSE (percentage): 3 (14);
Total (percentage): 229 (21).
Fiscal year: 2006;
FDA decision: SE (percentage): 242 (23);
FDA decision: NSE (percentage): 6 (29);
Total (percentage): 248 (23).
Fiscal year: 2007;
FDA decision: SE (percentage): 209 (20);
FDA decision: NSE (percentage): 1 (5);
Total (percentage): 210 (19).
Fiscal year: Total;
FDA decision: SE (percentage): 1,061 (100);
FDA decision: NSE (percentage): 21 (100);
Total (percentage): 1,082 (100).
Source: GAO analysis of FDA data.
Note: Percentages may not sum to 100 because of rounding.
[End of table]
Table 11 shows the third-party review 510(k) submissions by medical
specialty.
Table 11: Third-Party Review 510(k) Submissions by Medical Specialty,
Fiscal Years 2003 through 2007:
Medical specialty: Radiology;
Frequency: 411;
Percentage: 38.7.
Medical specialty: General and plastic surgery;
Frequency: 120;
Percentage: 11.3.
Medical specialty: Cardiovascular;
Frequency: 116;
Percentage: 10.9.
Medical specialty: General hospital;
Frequency: 98;
Percentage: 9.2.
Medical specialty: Dental;
Frequency: 52;
Percentage: 4.9.
Medical specialty: Gastroenterology and urology;
Frequency: 49;
Percentage: 4.6.
Medical specialty: Anesthesiology;
Frequency: 45;
Percentage: 4.2.
Medical specialty: Neurology;
Frequency: 45;
Percentage: 4.2.
Medical specialty: Physical medicine;
Frequency: 43;
Percentage: 4.1.
Medical specialty: Ophthalmic;
Frequency: 25;
Percentage: 2.4.
Medical specialty: Obstetrics and gynecology;
Frequency: 22;
Percentage: 2.1.
Medical specialty: Clinical chemistry;
Frequency: 13;
Percentage: 1.2.
Medical specialty: Ear, nose, and throat;
Frequency: 7;
Percentage: 0.7.
Medical specialty: Clinical toxicology;
Frequency: 4;
Percentage: 0.4.
Medical specialty: Microbiology;
Frequency: 4;
Percentage: 0.4.
Medical specialty: Hematology;
Frequency: 3;
Percentage: 0.3.
Medical specialty: Orthopedic;
Frequency: 3;
Percentage: 0.3.
Medical specialty: Immunology;
Frequency: 1;
Percentage: 0.1.
Medical specialty: Total;
Frequency: 1,061;
Percentage: 100.
Source: GAO analysis of FDA data.
Note: Percentages may not sum to 100 because of rounding.
[End of table]
[End of section]
Appendix III: FDA's Implementation of Safe Medical Devices Act
Provisions:
The Safe Medical Devices Act of 1990 (SMDA) amended the definition of
class II devices[Footnote 55] and required FDA, for each preamendment
class III device type and before December 1, 1995, to (1) order
manufacturers to submit information on safety and effectiveness to FDA
and (2) publish proposed and final regulations to reclassify each
device type into class II or class I or to require it to remain in
class III. For those devices for which FDA published a regulation
requiring the device to remain in class III, the SMDA further directed
FDA to, as promptly as reasonably achievable but not later than 12
months after the effective date of the regulation requiring the device
to remain in class III, establish a schedule for the promulgation of
regulations requiring the submission of PMAs.
In an April 19, 1994, memorandum from the Acting Director of the FDA
Center for Devices and Radiological Health's Office of Device
Evaluation, FDA outlined its strategy for implementation of the SMDA.
Specifically, FDA grouped 117 preamendment class III device types for
which FDA had not yet initiated any action to require the submission of
PMAs into three groups and prioritized the devices to facilitate the
SMDA activities. (See table 12.) The agency's proposed strategy
established a plan for beginning to address the class III device types
that were continuing to be reviewed through the 510(k) process, but did
not establish completion dates for doing so.
Table 12: FDA Groupings and Time Frames for Implementation of SMDA
Provisions for Class III Device Types in 1994 and Status as of October
2008:
Group 3 (device types designated high priority):
Number of device types: 15.
Description: Group 3 contains devices that were not considered
candidates for reclassification and that FDA believed were in
commercial distribution and would require submission of PMAs in the
near future; The high-priority subgroup of group 3 contains devices FDA
determined presented an unreasonably high risk to public health because
significant issues of safety, effectiveness, or both were not being
resolved or, to the best of FDA's knowledge, had little probability of
being resolved.
Examples: Certain types of hip joints and shoulder joints, ultrasound
and muscle stimulator.
Planned schedule: FDA planned to publish proposed rules related to
these 15 device types by 1996. In its 1994 strategy memorandum, FDA
noted that the timetable for publication of each final rule would be
based upon specific data needs, comments received, and the existence,
if any, of any petitions to reclassify the devices that FDA needed to
review.
Status as of October 2008: Of the 15 device types designated high
priority in group 3, 5 were reclassified, 6 now require PMAs, and 4 may
still be cleared through the 510(k) process.
Group 3 (other device types):
Number of device types: 27.
Description: Group 3 contains devices that were not considered
candidates for reclassification and that FDA believed were in
commercial distribution and would require submission of PMAs in the
near future. The devices in group 3 that were not designated high
priority were not considered candidates for reclassification, but FDA
planned to assess whether these devices should be moved to group 2. FDA
stated that the continued marketing of these group 3 devices did not
present as great a risk to the public health, in light of FDA's
knowledge and experience with the devices, as the device types
designated high priority.
Examples: External pacemaker pulse generator, stairclimbing wheelchair.
Planned schedule: FDA planned to pursue the same course of evaluation
and prioritization as used for group 2 device types.
Status as of October 2008: Of the 27 other device types in group 3 that
were not designated high priority, 13 were reclassified, 7 now require
PMAs, and 7 may still be cleared through the 510(k) process.
Group 2:
Number of device types: 31.
Description; Group 2 contains devices that FDA believed had a high
potential for reclassification into class II and for which existing
questions of safety, effectiveness, or both had been or could be
answered by information already obtained or being obtained by
manufacturers. According to FDA, the SMDA-modified definition of class
II devices together with increased experience with these device types
might provide grounds for reclassification of group 2 devices.
Examples; Tweezer-type epilator, cardiovascular permanent pacemaker
electrodes, implanted blood access device.
Planned schedule; FDA planned to issue an order requiring manufacturers
to submit all safety and effectiveness information available or known
to them, including adverse information, for all group 2 device types,
to complete a review and evaluation of this safety and effectiveness
information, and to proceed with rule making to reclassify these device
types or retain them in class III by 1998. The 1994 memorandum did not
specify any dates for publication of final regulations reclassifying
devices or requiring them to remain in class III.
Status as of October 2008: Of the 31 device types in group 2, 23 were
reclassified, 1 now requires a PMA, and 7 may still be cleared through
the 510(k) process (this includes 1 case in which the device type was
reclassified for some purposes but remains class III for others).
Group 1:
Number of device types: 44.
Description: Group 1 contains device types that FDA identified as
having fallen into disuse or limited use. FDA determined that these
device types raise significant questions of safety, effectiveness, or
both but are rarely in current use. FDA believed that rule making
requiring PMAs for these device types would be unlikely to result in
viable PMAs or reclassification petitions.
Examples; Catheter balloon repair kit; certain types of hip joints,
finger joints, and shoulder joints.
Planned schedule: FDA planned to publish one proposed regulation in
1994 requiring PMAs for all group 1 devices. The 1994 memorandum did
not specify any dates for publication of final regulations.
Status as of October 2008; Of the 44 device types in group 1, 4 were
reclassified, 39 now require PMAs, and 1 may still be cleared through
the 510(k) process.
All groups:
Number of device types: 117.
Status as of October 2008: Of the 117 device types contained in FDA's
strategy document, 45 have been reclassified, 53 now require PMAs, and
19 may still be cleared through the 510(k) process.
Source: GAO.
Note: In addition, the 1994 memorandum listed additional device types
for which some action had been taken toward reclassification or
requiring PMA submissions. For example, the memorandum listed device
types, including endosseous (dental) implants, with reclassification
petitions pending.
[End of table]
As of October 2008, FDA had reclassified 45 device types and published
regulations requiring PMAs for 53 device types. Therefore, of the 117
preamendment class III device types covered by FDA's strategy, 19
device types remain in class III and may be cleared through the 510(k)
process.[Footnote 56] Four of those 19 device types are types that FDA
had placed in group 3 and designated high priority--that is, they are
device types that FDA had determined to present an unreasonably high
risk to public health because significant issues of safety or
effectiveness were not being resolved or, to the best of FDA's
knowledge, had little probability of being resolved.
[End of section]
Appendix IV: Additional Information on 510(k) Submissions for Class III
Devices Reviewed by FDA:
This appendix summarizes the results from GAO analysis of FDA's data
for class III 510(k) submissions with FDA review decisions in fiscal
years 2003 through 2007. The following tables show FDA's final
decisions for submissions for class III devices for each fiscal year
through the 510(k) process (table 13); the primary medical specialties
for submissions for class III devices cleared through the 510(k)
process (table 14); and a detailed list of all device types covered by
the class III devices cleared through the 510(k) process, including the
status of these device types as of October 2008 (table 15).
Table 13: FDA Review Decisions for Class III 510(k) Submissions by
Fiscal Year, Fiscal Years 2003 through 2007:
Fiscal Year: 2003;
FDA Decision: SE (percentage of row): 58 (80%);
FDA Decision: NSE (percentage of row): 12 (16%);
FDA Decision: Other[A] (percentage of row): 3 (4%);
Total (percentage of row): 73 (100%).
Fiscal Year: 2004;
FDA Decision: SE (percentage of row): 68 (80%);
FDA Decision: NSE (percentage of row): 13 (15%);
FDA Decision: Other[A] (percentage of row): 4 (5%);
Total (percentage of row): 85 (100%).
Fiscal Year: 2005;
FDA Decision: SE (percentage of row): 31 (52%);
FDA Decision: NSE (percentage of row): 27 (45%);
FDA Decision: Other[A] (percentage of row): 2 (3%);
Total (percentage of row): 60 (100%).
Fiscal Year: 2006;
FDA Decision: SE (percentage of row): 32 (50%);
FDA Decision: NSE (percentage of row): 31 (48%);
FDA Decision: Other[A] (percentage of row): 1 (2%);
Total (percentage of row): 64 (100%).
Fiscal Year: 2007;
FDA Decision: SE (percentage of row): 39 (65%);
FDA Decision: NSE (percentage of row): 17 (28%);
FDA Decision: Other[A] (percentage of row): 4 (7%);
Total (percentage of row): 60 (100%).
Fiscal Year: Total;
FDA Decision: SE (percentage of row): 228 (67%);
FDA Decision: NSE (percentage of row): 100 (29%);
FDA Decision: Other[A] (percentage of row): 14 (4%);
Total (percentage of row): 342 (100%).
Source: GAO analysis of FDA data.
[A] Other decisions include submissions that were withdrawn, exempted
by regulation, not responsive to FDA's requests within a specified time
frame, forwarded to another FDA center or office, duplicates,
determined not to be a device, or not actively regulated by FDA.
[End of table]
Table 14: Primary Medical Specialties of Class III 510(k) Submissions
Cleared in Fiscal Years 2003 through 2007:
Medical specialty: Cardiovascular;
Frequency: 64;
Percentage: 28.
Medical specialty: Orthopedic;
Frequency: 54;
Percentage: 24.
Medical specialty: Gastroenterology and urology;
Frequency: 36;
Percentage: 16.
Medical specialty: Dental;
Frequency: 31;
Percentage: 14.
Medical specialty: Physical medicine;
Frequency: 19;
Percentage: 8.
Medical specialty: Neurology;
Frequency: 14;
Percentage: 6.
Medical specialty: Microbiology;
Frequency: 7;
Percentage: 3.
Medical specialty: General and plastic surgery;
Frequency: 2;
Percentage: 1.
Medical specialty: Obstetrics and gynecology;
Frequency: 1;
Percentage: 1.
Medical specialty: Total;
Frequency: 228;
Percentage: 100.
Source: GAO analysis of FDA data.
Note: Totals may not sum to 100 because of rounding.
[End of table]
Table 15: Device Types with Class III 510(k) Submissions Cleared in
Fiscal Years 2003 through 2007 and Their Status as of October 2008:
Device types included in group 3 and designated high priority in FDA's
1994 strategy[A]:
Device type (regulation number): Iontophoresis device[B](21 C.F.R. §
890.5525(B));
Number of submissions cleared in FYs 2003-2007: 18;
Actions taken as of October 2008: FDA published a notice of intent to
reclassify this device type in 2000. FDA has not issued a regulation
reclassifying or requiring PMA submissions for this device type. It
remains a class III type that may be cleared through the 510(k)
process.
Device type (regulation number): Hip joint metal/metal semiconstrained,
with an uncemented acetabular component, prosthesis (21 C.F.R. §
888.3330);
Number of submissions cleared in FYs 2003-2007: 18;
Actions taken as of October 2008: FDA rejected one petition to
reclassify this device type in 2002 and received another classification
petition in 2005. According to FDA officials, the agency is reviewing
the reclassification petition that it received in 2005. While it is
doing so, this remains a class III device type that may be cleared
through the 510(k) process.
Device type (regulation number): Hip joint metal/metal semi-
constrained, with a cemented acetabular component, prosthesis (21
C.F.R. § 888.3320);
Number of submissions cleared in FYs 2003-2007: 2;
Actions taken as of October 2008:
FDA rejected one petition to reclassify this device type in 2002 and
received another classification petition in 2005. According to FDA
officials, the agency is reviewing the petition that it received in
2005. While it is doing so, this remains a class III device type that
may be cleared through the 510(k) process.
Device type (regulation number): Shortwave diathermy[C](21 C.F.R. §
890.5290);
Number of submissions cleared in FYs 2003-2007: 1;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1997. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device types included in group 3 (but not designated high priority) in
FDA's 1994 strategy[A]:
Device type (regulation number): Neurovascular embolization
device[D](21 C.F.R. § 882.5950);
Number of submissions cleared in FYs 2003-2007: 11;
Actions taken as of October 2008: FDA reclassified this device type to
class II effective January 28, 2005.
Device type (regulation number): External counter-pulsating device (21
C.F.R. § 870.5225);
Number of submissions cleared in FYs 2003-2007: 9;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by February 14, 1997. FDA
has not issued a regulation reclassifying or requiring PMA submissions
for this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): Arrythmia detector and alarm (21
C.F.R. § 870.1025);
Number of submissions cleared in FYs 2003-2007: 7;
Actions taken as of October 2008: FDA reclassified this device type to
class II effective November 28, 2003.
Device type (regulation number): Vascular embolization device[D](21
C.F.R. § 870.3300);
Number of submissions cleared in FYs 2003-2007: 4;
Actions taken as of October 2008: FDA reclassified this device type to
class II effective January 28, 2005.
Device type (regulation number): Intra-aortic balloon and control
system (21 C.F.R. § 870.3535);
Number of submissions cleared in FYs 2003-2007: 2;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1997. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): Sorbent hemoperfusion system (21
C.F.R. § 876.5870);
Number of submissions cleared in FYs 2003-2007: 1;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by February 14, 1998. FDA
has not issued a regulation reclassifying or requiring PMA submissions
for this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): External pacemaker pulse generator (21
C.F.R. § 870.3600);
Number of submissions cleared in FYs 2003-2007: 1;
Actions taken as of October 2008: FDA that requested manufacturers
submit safety and effectiveness information by August 14, 1997. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device types included in group 2 in FDA's 1994 strategy[A]:
Device type (regulation number): Blood access device (implanted) (21
C.F.R. § 876.5540(b)(1));
Number of submissions cleared in FYs 2003-2007: 35;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1998. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): Herpes simplex virus serological
assays[D](21 C.F.R. § 866.3305);
Number of submissions cleared in FYs 2003-2007: 7;
Actions taken as of October 2008: FDA reclassified this device type to
class II for type 1 and/or type 2 serological assays effective May 3,
2007; all other assays remain class III and may be cleared through the
510(k) process. According to FDA, the seven class III 510(k)
submissions for herpes simplex virus serological assays cleared in
fiscal years 2003 through 2007 were for type 1 and/or type 2
serological assays.
Device type (regulation number): External cardiac compressor (21 C.F.R.
§ 870.5200);
Number of submissions cleared in FYs 2003-2007: 4;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1998. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): Topical oxygen chamber for extremities
(21 C.F.R. § 878.5650);
Number of submissions cleared in FYs 2003-2007: 2;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1997; FDA
published a proposal to reclassify in 2006. FDA has not issued a
regulation reclassifying or requiring PMA submissions for this device
type. It remains a class III type that may be cleared through the
510(k) process.
Device type (regulation number): Cardiovascular pacemaker electrodes
(permanent) (21 C.F.R. § 870.3680);
Number of submissions cleared in FYs 2003-2007: 1;
Actions taken as of October 2008: FDA requested that manufacturers
submit safety and effectiveness information by August 14, 1997. FDA has
not issued a regulation reclassifying or requiring PMA submissions for
this device type. It remains a class III type that may be cleared
through the 510(k) process.
Other[E]:
Device type (regulation number): Pedicle screw spinal system[F](21
C.F.R. § 888.3070(B)(2));
Number of submissions cleared in FYs 2003-2007: 34;
Actions taken as of October 2008: In 2001, FDA stated that it intended
to initiate the call for PMAs for the device when intended for certain
uses in a future Federal Register notice. FDA has not issued a
regulation reclassifying or requiring PMA submissions for this device
type. It remains a class III type that may be cleared through the
510(k) process.
Device type (regulation number): Automated external defibrillator (21
C.F.R. § 870.5310);
Number of submissions cleared in FYs 2003-2007: 30;
Actions taken as of October 2008:
In 2003, FDA began to regulate automated external defibrillators
separately from arrhythmia detectors and alarms; at that time, the
agency published a notice of intent to initiate a proceeding to
reclassify. FDA has not issued a regulation reclassifying or requiring
PMA submissions for this device type. It remains a class III type that
may be cleared through the 510(k) process.
Device type (regulation number): Endosseous dental implant (blade form)
(21 C.F.R. § 872.3640(b)(2));
Number of submissions cleared in FYs 2003-2007: 26;
Actions taken as of October 2008: FDA reclassified this device type to
class II for root-form endosseous dental implants effective June 11,
2004; blade-form endosseous dental implants remain class III and may be
cleared through the 510(k) process.
Device type (regulation number): Endosseous dental implant abutment (21
C.F.R. § 872.3630);
Number of submissions cleared in FYs 2003-2007: 4;
Actions taken as of October 2008: FDA reclassified this device type to
class II effective June 11, 2004.
Device type (regulation number): Nonroller-type cardiopulmonary bypass
blood pump (21 C.F.R. § 870.4360);
Number of submissions cleared in FYs 2003-2007: 5;
Actions taken as of October 2008: FDA had published a proposal to
reclassify the device in 1993 and withdrew that proposal in 2004. FDA
has not issued a regulation reclassifying or requiring PMA submissions
for this device type. It remains a class III type that may be cleared
through the 510(k) process.
Device type (regulation number): Cranial electrotherapy stimulator (21
C.F.R. § 882.5800);
Number of submissions cleared in FYs 2003-2007: 3;
Actions taken as of October 2008: FDA had required PMA submissions for
this device type in 1995 but revoked that regulation in 1997. FDA
requested safety and effectiveness information from manufacturers in
1997. FDA has not issued a regulation reclassifying or requiring PMA
submissions for this device type. It remains a class III type that may
be cleared through the 510(k) process.
Device type (regulation number): Mandibular condyle prosthesis
(temporary)[G](21 C.F.R. § 872.3960);
Number of submissions cleared in FYs 2003-2007: 1;
Actions taken as of October 2008: FDA amended the regulation in 1998
stating that no effective date had been established for the submission
of PMAs for the implanted version of the device used for temporary
reconstruction. In the applicable Federal Register notice, FDA added
that at a later date, it would propose reclassifying from class III to
class II the generic type of temporary mandibular condyle prosthesis
intended for temporary reconstruction following surgical ablation of
malignant and benign tumors. FDA has not issued a regulation
reclassifying or requiring PMA submissions for this device type. It
remains a class III type that may be cleared through the 510(k)
process.
Device type (regulation number): Pericardial patch;
Number of submissions cleared in FYs 2003-2007: 2;
Actions taken as of October 2008:
According to agency officials, FDA is in the process of determining how
to address the situation under which FDA cleared two submissions for
this type of class III device through the 510(k) process).
Source: GAO.
Notes: No submissions with device types included in group 1 of FDA's
1994 strategy were cleared in fiscal years 2003 through 2007.
Generally, the name of the device type is the title of the relevant
provision in the 2008 edition of title 21 of the Code of Federal
Regulations.
[A] For a detailed description of the device types covered by FDA's
1994 strategy, see appendix III.
[B] For uses other than (1) the diagnosis of cystic fibrosis or (2)
those indicated on the label of the drug used with the device if the
label includes adequate directions for the device's use with the drug.
[C] For uses other than (1) the treatment of malignancies or (2) the
generation of deep heat within body tissues to treat conditions such as
pain, muscle spasms, and joint contractures.
[D] During the period of our review, FDA renamed these devices: the
neurovascular embolization device, vascular embolization device, and
herpes simplex virus serological assays were previously know as the
artificial embolization device, arterial embolization device, and
herpes simplex virus serological reagents, respectively.
[E] Other includes device types for which FDA had already taken some
action by 1994 (for example, FDA indicated that it had reclassification
petitions pending for some device types in 1994) as well as new device
types that FDA established after 1994 (for example, FDA added a
regulation for a subset of one device type).
[F] When intended to provide immobilization and stabilization of spinal
segments in the thoracic, lumbar, and sacral spine as an adjunct to
fusion in the treatment of degenerative disc disease and
spondylolisthesis other than either severe spondylolisthesis (grades 3
and 4) at L5-S1 or degenerative spondylolisthesis with objective
evidence of a neurologic impairment.
[G] In 1998 FDA issued a regulation requiring PMAs for mandibular
condyle prostheses intended for permanent reconstruction.
[End of table]
[End of section]
Appendix V: FDA's 510(k) Decision-Making Process:
This appendix presents the additional information from GAO analysis of
FDA's 510(k) submission files for which FDA reached a determination of
SE or NSE in fiscal years 2005 through 2007. The following figures show
FDA's detailed decision-making process for class II and class III
submissions (figure 9); the decision-making process for class II
devices alone (figure 10); and the decision-making process for class
III devices alone (figure 11).
Figure 9: Projected Percentages of 510(k) Submissions for Class II and
Class III Devices in Fiscal Years 2005 through 2007 Reaching Each Point
in FDA's Detailed Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the projected percentages of 510(k)
submissions for Class II and Class III devices in fiscal years 2005
through 2007 reaching each point in FDA's detailed decision-making
process, as follows:
Number: 5,063.
New device is compared to a predicate device:
[Descriptive information about new or marketed device requested as
needed]
1) Does the device have the same indication statement?
Yes: go to step 3 (87.1%);
No: go to step 2 (12.3%).
2) Do differences alter the intended effect of the device?
Yes: go to step 3 (0.7%);
No: go to step 4 (11.5%).
3) New device has new intended use:
Go to step 17 (0.7%).
4) New device has new intended use (98.6%): Does the new device have
the same technological characteristics?
Yes: go to step 7 (83.2%);
No: go to step 5 (15.4%).
5) Could the new characteristics affect safety or effectiveness?
Yes: go to step 6 (8.6%);
No: go to step 10 (6.8%).
6) Do the new technological characteristics raise new types of safety
or effectiveness questions?
Yes: go to step 17 (0.5%);
No: go to step 13 (8.1%).
7) Are the descriptive characteristics precise enough to ensure
equivalence?
Yes: go to step 16 (48.0%);
No: go to step 8 (35.2%).
8) Are performance data available to assess equivalence?[A]
Yes: go to step 9 (35.2%);
9) Do performance data demonstrate equivalence?
Yes: go to step 16 (33.5%);
No: go to step 17 1.7%).
10) Are the descriptive characteristics precise enough to ensure
equivalence? [Box 4]
Yes: go to step 16 (2.4%);
No: go to step 11 (4.4%).
11) Are performance data available to assess equivalence?[A]
Yes: go to step 12 [4.4%);
12) Do performance data demonstrate equivalence?
Yes: go to step 16 (4.2%);
No: go to step 17 (0.2%).
13) Do accepted scientific methods exist for assessing effects of the
new characteristics?
Yes: go to step 14 (8.1%);
No: go to step 17 (0%).
14) Are performance data available to assess effects of new
characteristics?[A]
Yes: go to step 15 (8.1%).
15) Do performance data demonstrate equivalence?
Yes: go to step 16 (7.0%);
No: go to step 17 (1.1%).
16) Substantially Equivalent (SE) (95.1%).
17) Not Substantially Equivalent (NSE) (4.9%).
Note: The sampling errors of the estimated percentages of 510(k)
submissions reaching SE or NSE in FDA's decision-making process are
within plus or minus 1 percentage point at the 95 percent confidence
level.
[A] Performance data may be contained in the 510(k) submission, other
510(k) submissions, the center's classification files, or academic
literature. In cases where FDA determines that performance data are not
available, FDA requests data from the applicant.
[B] In 0.6 percent of the 5,063 cases, FDA made a determination of NSE,
but the determination path is not represented in this flowchart.
Reasons that these cases were found NSE include: the applicant failing
to respond to an FDA data request and a PMA already being required for
the device type.
[End of figure]
Figure 10: Projected Percentages of 510(k) Submissions for Class II
Devices in Fiscal Years 2005 through 2007 Reaching Each Point in FDA's
Decision-Making Process:
[Refer to PDF for image]
This figure is an illustration of the projected percentages of 510(k)
submissions for Class II devices in fiscal years 2005 through 2007
reaching each point in FDA's decision-making process, as follows:
Number: 4,900.
New device is compared to a predicate device:
Step 1: Does the device have the same indication statement?
Yes: go to step 2 (99.3%);
No: Not Substantially Equivalent (NSE) (0.3%).
Step 2: Does the new device have the same technological
characteristics?
Yes: go to step 5 (84.5%);
No: go to step 3 (14.9).
Step 3: Do the new technological characteristics raise new types of
safety or effectiveness questions?
Yes: Not Substantially Equivalent (NSE)(0.1%);
No: go to step 4 (14.7%).
Step 4: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE) (13.6%);
No: Not Substantially Equivalent (NSE) (1.2%).
Step 5: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE) (82.7%);
No: Not Substantially Equivalent (NSE) (1.8%).
Substantially Equivalent (NSE): 96.3%;
Not Substantially Equivalent (NSE): 3.7%[B].
Source: GAO analysis of FDA files.
Notes: In cases where FDA determines that a new device has new
technological characteristics that could not affect safety and
effectiveness, the device may be determined SE if descriptive
characteristics alone are precise enough to ensure equivalence. In
cases where FDA determines that a new device has new technological
characteristics that could affect safety and effectiveness, FDA
requires performance data to demonstrate substantial equivalence. For
cases in which descriptive or performance information is insufficient,
FDA requests additional information.
The sampling errors of the estimated percentages of 510(k) submissions
for class II devices reaching SE or NSE in FDA's decision-making
process are within plus or minus 1 percentage point at the 95 percent
confidence level.
[A] For devices with new technological characteristics, FDA first
examines whether the new technological characteristics could affect
safety or effectiveness.
[B] In 0.4 percent of the 4,900 class II cases, FDA made a
determination of NSE, but the determination path is not represented in
this flowchart. Reasons that these cases were found NSE include the
applicant failing to respond to an FDA data request and a PMA already
being required for the device type.
[End of figure]
Figure 11: Percentages of 510(k) Submissions for Class III Devices in
Fiscal Years 2005 through 2007 Reaching Each Point in FDA's Decision-
Making Process:
[Refer to PDF for image]
This figure is an illustration of the percentages of 510(k) submissions
for Class III devices in fiscal years 2005 through 2007 reaching each
point in FDA's decision-making process, as follows:
Number: 163.
New device is compared to a predicate device:
Step 1: Does the device have the same indication statement?
Yes: go to step 2 (78.5%);
No: Not Substantially Equivalent (NSE) (13.5%).
Step 2: Does the new device have the same technological
characteristics?
Yes: go to step 5 (46.6%);
No: go to step 3 (31.9).
Step 3: Do the new technological characteristics raise new types of
safety or effectiveness questions?
Yes: Not Substantially Equivalent (NSE)(12.9%);
No: go to step 4 (19.0%).
Step 4: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE) (14.1%);
No: Not Substantially Equivalent (NSE) (4.9%).
Step 5: Do descriptive or performance data demonstrate equivalence?
Yes: Substantially Equivalent (NSE) (46.0%);
No: Not Substantially Equivalent (NSE) (0.6%).
Substantially Equivalent (NSE): 60.1%;
Not Substantially Equivalent (NSE): 39.9%[B].
Source: GAO analysis of FDA files.
Notes: In cases where FDA determines that a new device has new
technological characteristics that could not affect safety and
effectiveness, the device may be determined SE if descriptive
characteristics alone are precise enough to ensure equivalence. In
cases where FDA determines that a new device has new technological
characteristics that could affect safety and effectiveness, FDA
requires performance data to demonstrate substantial equivalence. For
cases in which descriptive or performance information is insufficient,
FDA requests additional information.
Totals may not sum to 100 because of rounding.
[A] For devices with new technological characteristics, FDA first
examines whether the new technological characteristics could affect
safety or effectiveness.
[B] In 7.9 percent of the 163 class III cases, FDA made a determination
of NSE, but the determination path is not represented in this
flowchart. Reasons that these cases were found NSE include: the
applicant failing to respond to an FDA data request and a PMA already
being required for the device type.
[End of figure]
[End of section]
Appendix VI: Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary For Legislation:
Washington, DC 20201:
December 23, 2008:
Marcia Crosse:
Director, Health Care:
Government Accountability Office:
441 G Street NW:
Washington, DC 20548:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled: "Medical Devices:
FDA Should Take Steps to Ensure That High-Risk Device Types Are
Approved through the Most Stringent Premarket Review Process" (GAO-09-
190).
The Department appreciates the opportunity to review and comment on
this report before its publication.
Sincerely,
Signed by:
Jennifer R. Luong, for:
Vincent J. Ventimiglia, Jr.
Assistant Secretary for Legislation:
Attachment:
General Comments Of The U.S. Department Of Health And Human Services
(HHS) On The U.S. Government Accountability Office's (GAO) Draft Report
Entitled: Medical Devices: FDA Should Take Steps To Ensure That High
Risk Device Types Are Approved Through The Most Stringent Premarket
Review Process (GAO 09-190):
In general, we believe GAO's draft report fairly and accurately
describes the Food and Drug Administration's (FDA) medical device
premarket notification (510(k)) program. We agree with GAO's
conclusions and recommendation to expeditiously take steps to either
reclassify or call for PMAs for each class III device type currently
allowed to enter the market through the premarket notification process.
FDA is committed to resolving the classification and premarket
submission type for the remaining preamendment class III devices
currently subject to 510(k). Since 1994, FDA has called for premarket
approval applications (PMAs) or reclassified the majority of class III
device types not requiring PMA at that time. In recent months, prior to
the issuance of this report, FDA officials have met internally to
discuss the most appropriate and expeditious method to require all
class Ill device types to be approved through the PMA process. FDA is
considering its legal and procedural options for completing this task
as expeditiously as possible, consistent with available resources and
competing priorities.
[End of section]
Appendix VII: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7114 or crossem@gao.gov:
Acknowledgments:
In addition to the contact named above, Kim Yamane, Assistant Director;
Susannah Bloch; Matt Byer; Sean DeBlieck; Linda Galib; Julian Klazkin;
and Dan Ries made key contributions to this report.
[End of section]
Related GAO Products:
Medical Devices: FDA Faces Challenges in Conducting Inspections of
Foreign Manufacturing Establishments. [hyperlink,
http://www.gao.gov/products/GAO-08-780T]. Washington, D.C.: May 14,
2008.
Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased,
and Available Information Does Not Indicate That Use Presents an
Elevated Health Risk. [hyperlink,
http://www.gao.gov/products/GAO-08-147]. Washington, D.C.: January 31,
2008.
Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections. [hyperlink, http://www.gao.gov/products/GAO-08-428T].
Washington, D.C.: January 29, 2008.
Medical Devices: FDA's Approval of Four Temporomandibular Joint
Implants. [hyperlink, http://www.gao.gov/products/GAO-07-996].
Washington, D.C.: September 17, 2007.
Medical Devices: Status of FDA's Program for Inspections by Accredited
Organizations. [hyperlink, http://www.gao.gov/products/GAO-07-157].
Washington, D.C.: January 5, 2007.
Food and Drug Administration: Limited Available Data Indicate That FDA
Has Been Meeting Some Goals for Review of Medical Device Applications.
[hyperlink, http://www.gao.gov/products/GAO-05-1042]. Washington, D.C.:
September 30, 2005.
Food and Drug Administration: Data to Measure the Timeliness of Reviews
of Medical Device Applications Are Limited. [hyperlink,
http://www.gao.gov/products/GAO-04-1022]. Washington, D.C.: August 30,
2004.
[End of section]
Footnotes:
[1] Generally, medical devices include items used for the diagnosis,
cure, mitigation, treatment, or prevention of a disease. See 21 U.S.C.
§ 321(h). Throughout this report, the term device refers to a medical
device that is not being regulated as a drug or a biological product.
[2] Throughout this report we refer to type of device or device type to
indicate a generic category of device, which has a particular intended
use (for example, a scalpel is intended to cut tissue) and which may
include a variety of models made by different manufacturers. FDA's
classifications of device types are codified in parts 862 through 892
of title 21 of the Code of Federal Regulations; in addition, FDA's Web
site provides searchable databases at [hyperlink,
http://www.fda.gov/cdrh/databases.html]. Class I devices are those for
which compliance with general controls, such as good manufacturing
practices specified in FDA's quality system regulation, are sufficient
to provide reasonable assurance of their safety and effectiveness.
Class II devices are subject to general controls and may also be
subject to special controls, such as postmarket surveillance. Class II
devices may support or sustain human life. For class II devices that
are represented or purported to be used for those purposes, FDA must
examine, identify, and describe the special controls necessary to
provide assurance of their safety and effectiveness. Class III devices
are those (1) for which insufficient information exists to determine
whether general and special controls are sufficient to provide a
reasonable assurance of the safety and effectiveness of the devices and
(2) that support or sustain human life or are of substantial importance
in preventing impairment of human health, or that present a potential
unreasonable risk of illness or injury. See 21 U.S.C. § 360c.
[3] A small percentage of devices enter the market by other means, such
as through the humanitarian device exemption process that allows market
entry, without adherence to certain requirements, for devices
benefiting patients with rare diseases or conditions. See 21 U.S.C. §
360j(m), 21 C.F.R. pt. 814, subpart H (2008).
[4] Substantial equivalence or substantially equivalent means that the
device has the same intended use as another legally marketed device and
the same technological characteristics, or different technological
characteristics and submitted information demonstrates that the device
is as safe and effective as the legally marketed device and does not
raise different questions of safety or effectiveness. See 21 U.S.C. §
360c(i)(1)(A).
[5] Some devices are exempt from premarket notification requirements.
Most class I and some class II device types are in this exempt
category. In these cases, the manufacturers must still register and
list the devices with FDA.
[6] May 28, 1976, is the date of enactment of the Medical Device
Amendments of 1976, which established the three device classes. See
Pub. L. No. 94-295, 90 Stat. 539.
[7] Based on new information respecting a device, FDA may, upon its
initiative or upon petition of an interested person, by regulation
change the classification of a device from class III to (1) class II if
it determines that special controls would provide reasonable assurance
of the safety and effectiveness of the device and that general controls
alone would not provide reasonable assurance of the safety and
effectiveness of the device or (2) class I if FDA determines that
general controls alone would provide reasonable assurance of the safety
and effectiveness of the device. See 21 U.S.C. § 360c(e).
[8] Pub. L. No. 101-629, § 4(b), 104 Stat. 4511, 4515-17 (codified at
21 U.S.C. § 360c(i)).
[9] Pub. L. No. 110-85, § 225, 121 Stat. 823, 854.
[10] 21 U.S.C. § 360(k).
[11] Throughout this report, we refer to both submissions to FDA
through the 510(k) process and applications to FDA through the PMA
process as device submissions. Because related devices can be "bundled"
together in a single submission, one submission may include one or more
devices.
[12] The FDA-assigned product code for a device is based on the
classification designated under the relevant classification
regulations.
[13] For the purposes of this report, submissions for which FDA made
review decisions include cases in which FDA made a determination to
allow or disallow marketing of a device and cases in which FDA decided
to discontinue consideration for other reasons such as if the
manufacturer withdrew its submission. See appendix I for additional
information on our scope and methodology.
[14] Our analysis did not include certain types of device submissions,
for example, special 510(k) submissions, which are requests for
clearance of modifications to devices that have already been cleared
through the 510(k) process. Panel-track PMA supplements are requests
for approval for a significant change in design, performance, or use of
a device, for which clinical data are generally necessary to provide a
reasonable assurance of safety and effectiveness; 180-day PMA
supplements are requests for approval for a significant change in
components, materials, design, specification, software, color additive,
or labeling.
[15] See appendix I for additional information on our scope and
methodology.
[16] See appendix I for additional information on our scope and
methodology. Some 510(k) submissions may be reviewed by third parties.
For additional information on third-party review of 510(k) submissions,
see appendix II.
[17] Pub L. No. 94-295, § 2, 90 Stat. 539-41 (codified as amended at 21
U.S.C. § 360c(a)(1)).
[18] Before 1990, class II devices were defined as those for which
general controls alone were insufficient to provide reasonable
assurance of safety and effectiveness, but for which sufficient
information existed for FDA to establish a "performance standard" to
provide such assurance. Under the SMDA, this definition was revised to
include those devices for which sufficient information existed for FDA
to establish "special controls"--such as performance standards,
postmarket surveillance, patient registries, guidelines, and FDA
recommendations--to provide such assurance.
[19] Each manufacturer that wants to market a class I, II, or III
device intended for human use for which premarket approval is not
required must obtain marketing clearance by a 510(k) submission unless
FDA issues a regulation stating that the device type is exempt from the
510(k) premarket notification requirements of the FDCA.
[20] Manufacturers are required to register with FDA within 30 days
after operations begin and provide it with a list at that time of their
devices intended for commercial distribution. Registrations and device
listings must be updated annually. 21 U.S.C. § 360(j)(2)(A); 21 C.F.R.
§ 807.21 (2008).
[21] Regarding the devices listed with FDA that were not exempt from
premarket review, about 31 percent (15,472) of the listed devices were
allowed to enter the U.S. market through the 510(k) premarket
notification process, and about 1 percent (529) of the listed devices
were required to enter the U.S. market through the more stringent PMA
process. Approximately 1 percent (389) were allowed to enter the market
via other means, such as through the humanitarian device exemption
process. A humanitarian device exemption requires a submission that is
similar to a PMA submission, but does not include effectiveness
requirements. FDA approval of a humanitarian device exemption
authorizes the manufacturer to market a device intended to benefit
patients in the treatment or diagnosis of a disease or condition that
affects fewer than 4,000 individuals in the United States per year. See
21 U.S.C. § 360j(m); 21 C.F.R. pt. 814, subpart H.
[22] Pub. L. No. 94-295, 90 Stat. 539, 552-53 (codified at 21 U.S.C. §
360e).
[23] The act required FDA to promulgate regulations providing for the
premarket approval of preamendment class III devices.
[24] For both preamendment and postamendment class III devices, after
FDA issues a regulation setting an effective date requiring PMAs for a
particular device type, all devices of that type must obtain an
approved PMA to remain on the market. In addition, any new devices of
the same type subsequently entering the market must also go through the
PMA process--that is, they are no longer allowed to be cleared through
the 510(k) process.
[25] After FDA reclassifies the device type into a lower class, the
class I or class II device type would require clearance for the U.S.
market through the 510(k) process unless FDA also exempted the device
type from premarket notification requirements.
[26] For example, in 1988, GAO reported that FDA had called for
premarket approval applications for only 9 of approximately 150 types
of preamendment class III devices. See GAO, Medical Devices: FDA's
510(k) Operations Could Be Improved, GAO/PEMD-88-14 (Washington, D.C.:
Aug. 17, 1988).
[27] The SMDA required that (1) FDA publish a proposed regulation
regarding the classification of the device and provide reasonable
opportunity for the submission of comments and (2) the final
regulations regarding classification could not take effect until 90
days after the publication of a proposed regulation in the Federal
Register.
[28] 21 U.S.C. § 360e(i)(3). The SMDA required the schedule to be
established within 12 months of the effective date of the regulation
requiring a device to remain in class III. Under the FDCA, in order to
require PMAs for preamendment class III devices, FDA must take a number
of steps, including publishing a notice of proposed rule making,
allowing comments on the proposed rule, providing an opportunity to
request reclassification of the device based on new information, and
then publishing a final regulation requiring submission of PMAs. 21
U.S.C. § 360e(b).
[29] H.R. Rep. No. 101-808, at 6320 (1990).
[30] 59 Fed. Reg. 23731 (May 6, 1994).
[31] 21 C.F.R. § 807.92 (a)(3) (2008). Anyone submitting a 510(k) for a
device type that has not been previously classified and which FDA
subsequently classifies into class III, may, within 30 days after
receiving notice of such classification, request that FDA reclassify
the device under the statutory criteria for class I and class II
devices. This process, known as the de novo classification process,
permits FDA to establish a class I or II designation for devices that
do not have a predicate and to allow them to enter the U.S. market and
to serve as a predicate device for subsequent 510(k) submissions. 21
U.S.C. § 360c(f)(2).
[32] In addition to an FDA determination of SE or NSE, FDA may decide
to discontinue its review for other reasons, for example, if the
manufacturer withdraws its submission.
[33] According to FDA, performance testing should be submitted if there
are important descriptive differences between the device and other
devices of the same type or if the descriptive characteristics for the
new device are not precise enough to ensure comparability. In these
instances, the most appropriate bench testing, animal testing, or both
to address the performance issue should be provided, and summary
information regarding the testing should generally suffice.
[34] When clinical outcome can be reliably predicted from nonclinical
data, well-designed bench testing or animal testing or both can be the
basis for PMA approval.
[35] In addition to inspecting manufacturing establishments as part of
its premarket review of original PMA submissions, FDA may also conduct
inspections as part of the approval process for certain types of PMA
supplements.
[36] For additional information on FDA's inspection of device
manufacturing establishments, see GAO, Medical Devices: Challenges for
FDA in Conducting Manufacturer Inspections, [hyperlink,
http://www.gao.gov/products/GAO-08-428T] (Washington, D.C.: Jan. 29,
2008), and "Related GAO Products" at the end of this report.
[37] FDA's goals for original PMAs included panel-track PMA
supplements. For 180-day PMA supplements, FDA's fiscal year 2009 goal
is to review and decide upon 85 percent of submission within 180 days
and 95 percent of them within 210 days.
[38] In fiscal year 2009, the standard fee for a panel-track supplement
is $150,544 and the standard fee for a 180-day supplement is $30,109.
[39] See appendix IV for additional information on 510(k) submissions
for class III devices reviewed by FDA.
[40] See appendix IV for additional information on 510(k) submissions
for class III devices reviewed by FDA.
[41] For these device types, FDA determined that general controls alone
were insufficient to provide reasonable assurance of safety and
effectiveness and that sufficient information existed to establish
special controls to provide such assurance.
[42] This includes two device types that FDA reclassified to class II
under certain conditions, but retained the device type as class III
that may be cleared through the 510(k) process for other conditions.
For example, FDA reclassified endosseous dental implants to class II
for root-form implants, but retained the blade-form implants as class
III devices that may be cleared through the 510(k) process.
[43] All figures are estimates based on our sample of 510(k)
submissions. Our analysis of FDA files did not include submissions for
class I devices or submissions that did not receive a final
determination, such as submissions that were withdrawn. See appendix I
for additional information on the scope of our review.
[44] In this report, we refer to both 510(k) submissions and PMA
applications as device submissions. Because related devices can be
"bundled" together in a single submission, one submission may include
one or more devices.
[45] The FDA-assigned product code for a device is based on the
relevant classification regulation.
[46] For the purposes of this report, review decisions include cases
where FDA made a determination to allow or disallow marketing of a
device and cases where FDA decided to discontinue consideration for
other reasons.
[47] Our analysis also excluded de novo submissions. De novo
submissions are for first-of-a-kind devices lacking a legally marketed
predicate. Anyone submitting a 510(k) for a device type that has not
been previously classified and which FDA subsequently classifies into
class III may, within 30 days after receiving notice of such
classification, request that FDA reclassify the device under the
statutory criteria for class I and class II devices. The de novo
classification process permits FDA to establish a class I or II
designation for devices that do not have a predicate and allow them to
enter the U.S. market. See 21 U.S.C. § 360c(f)(2).
[48] Pub. L. No. 105-115, § 210, 111 Stat. 2296, 2342 (1997).
[49] As of August 6, 2008, FDA listed 11 accredited third parties that
can conduct third-party reviews of 510(k) submissions: (1) British
Standards Institution; (2) Center for Measurement Standards of
Industrial; (3) Cheiroon BV; (4) Citech; (5) Intertek Testing Services;
(6) Kema Quality B.V.; (7) Niom-Scandanavian Institute of Dental
Materials; (8) Regulatory Technology Services, LLC; (9) TUV Rheinland
of North America, Inc.; (10) TUV SUD America, Inc.; and (11)
Underwriters Laboratories, Inc.
[50] FDA does not maintain data on the amount of these fees, which are
negotiated between the 510(k) submitter and the third-party reviewer.
However, FDA officials estimate the fee to generally be in the $5,000
to $10,000 range.
[51] FDA initially identified 154 device types that were eligible for
third-party review. In March 2001, FDA expanded the program to allow
third parties to review 510(k) submissions for many class II device
types that were not previously eligible.
[52] 21 U.S.C. § 360m(a)(3)(A). In addition, in February 2001, FDA
issued guidance stating that third parties may not review 510(k)
submissions that require multiple FDA centers to review the device--for
example, for drug-device combination products--or if a center other
than the Center for Devices and Radiological Health, for example, the
Center for Biologics Evaluation and Research, has the primary
responsibility for the 510(k) review.
[53] FDA user fees for FDA review of medical device applications took
effect at the beginning of fiscal year 2003.
[54] According to FDA, in fiscal year 2005 the difference in average
review times between 510(k) submissions reviewed by third parties and
510(k) submissions reviewed entirely by FDA was 13 days, versus 45 days
in fiscal year 2000.
[55] Before enactment of the SMDA, class II devices were defined as
devices for which general controls alone were insufficient to provide
reasonable assurance of safety and effectiveness, but for which
sufficient information existed to establish a performance standard to
provide such assurance. Under the SMDA, the definition was revised to
include those devices for which sufficient information existed to
establish special controls to provide such assurance. In addition to
performance standards, special controls include postmarket
surveillance, patient registries, guidelines and recommendations, and
other appropriate actions as determined by FDA. The SMDA also stated
that for class II devices that purported or represented to be used for
supporting or sustaining human life, FDA was required to examine and
identify the necessary special controls and describe how they would
provide adequate assurance of safety and effectiveness.
[56] See appendix IV for information on class III device types that
were cleared through the 510(k) process in fiscal years 2003 through
2007.
[End of section]
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