Medical Devices
FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments Gao ID: GAO-08-780T May 14, 2008As part of the Food and Drug Administration's (FDA) oversight of the safety and effectiveness of medical devices marketed in the United States, it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement is based primarily on GAO testimonies from January 2008 (GAO-08-428T) and April 2008 (GAO-08-701T). In this statement, GAO assesses (1) FDA's program for inspecting foreign establishments that manufacture medical devices for the U.S. market and (2) FDA's programs for third-party inspections of those establishments. For GAO's January and April 2008 testimonies, GAO interviewed FDA officials, analyzed information from FDA, and updated GAO's previous work on FDA's programs for inspections by accredited third parties. GAO updated selected information for this statement in early May 2008.
FDA faces challenges managing its program to inspect foreign establishments that manufacture medical devices. GAO testified in January 2008 that two databases that provide FDA with information about foreign medical device establishments and the products they manufacture for the U.S. market contained inaccurate information about establishments subject to FDA inspection. In addition, comparisons between these databases--which could help produce a more accurate count--had to be done manually. Recent changes FDA made to its registration database could improve the accuracy of the count of establishments, but it is too soon to tell whether these and other changes will improve FDA's management of its foreign inspection program. Another challenge is that FDA conducts relatively few inspections of foreign establishments; officials estimated that the agency inspects foreign manufacturers of high-risk devices (such as pacemakers) every 6 years and foreign manufacturers of medium-risk devices (such as hearing aids) every 27 years. Finally, inspections of foreign manufacturers pose unique challenges to FDA, such as difficulties in recruiting investigators to travel to certain countries and in extending trips if the inspections uncovered problems. FDA is pursuing initiatives that could address some of these unique challenges, but it is unclear whether FDA's proposals will increase the frequency with which the agency inspects foreign establishments. Few inspections of foreign medical device manufacturing establishments have been conducted through FDA's two accredited third-party inspection programs--the Accredited Persons Inspection Program and the Pilot Multi-purpose Audit Program (PMAP). Under FDA's Accredited Persons Inspection Program, from March 11, 2004--the date when FDA first cleared an accredited organization to conduct independent inspections--through May 7, 2008, four inspections of foreign establishments had been conducted by accredited organizations. An incentive to participation in the program is the opportunity to reduce the number of inspections conducted to meet FDA's and other countries' requirements. Disincentives include bearing the cost for the inspection, particularly when the consequences of an inspection that otherwise might not occur in the near future could involve regulatory action. The Food and Drug Administration Amendments Act of 2007 made several changes to program eligibility requirements that could result in increased participation by manufacturers. PMAP was established on September 7, 2006, as a partnership between FDA and Canada's medical device regulatory agency and allows accredited organizations to conduct a single inspection to meet the regulatory requirements of both countries. As of May 7, 2008, two inspections of foreign establishments had been conducted by accredited organizations through this program. The small number of inspections completed to date by accredited third-party organizations raises questions about the practicality and effectiveness of these programs to quickly help FDA increase the number of foreign establishments inspected.
GAO-08-780T, Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
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Testimony:
Before the Subcommittee on Health, Committee on Energy and Commerce,
House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery:
Expected at 10:00 a.m. EDT:
Wednesday, May 14, 2008:
Medical Devices:
FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing
Establishments:
Statement of Marcia Crosse:
Director, Health Care:
GAO-08-780T:
GAO Highlights:
Highlights of GAO-08-780T, a testimony before the Subcommittee on
Health, Committee on Energy and Commerce, House of Representatives.
Why GAO Did This Study:
As part of the Food and Drug Administration‘s (FDA) oversight of the
safety and effectiveness of medical devices marketed in the United
States, it inspects certain foreign and domestic establishments where
these devices are manufactured. To help FDA address shortcomings in its
inspection program, the Medical Device User Fee and Modernization Act
of 2002 required FDA to accredit third parties to inspect certain
establishments. In response, FDA has implemented two voluntary programs
for that purpose.
This statement is based primarily on GAO testimonies from January 2008
(GAO-08-428T) and April 2008 (GAO-08-701T). In this statement, GAO
assesses (1) FDA‘s program for inspecting foreign establishments that
manufacture medical devices for the U.S. market and (2) FDA‘s programs
for third-party inspections of those establishments. For GAO‘s January
and April 2008 testimonies, GAO interviewed FDA officials, analyzed
information from FDA, and updated GAO‘s previous work on FDA‘s programs
for inspections by accredited third parties. GAO updated selected
information for this statement in early May 2008.
What GAO Found:
FDA faces challenges managing its program to inspect foreign
establishments that manufacture medical devices. GAO testified in
January 2008 that two databases that provide FDA with information about
foreign medical device establishments and the products they manufacture
for the U.S. market contained inaccurate information about
establishments subject to FDA inspection. In addition, comparisons
between these databases”which could help produce a more accurate
count”had to be done manually. Recent changes FDA made to its
registration database could improve the accuracy of the count of
establishments, but it is too soon to tell whether these and other
changes will improve FDA‘s management of its foreign inspection
program. Another challenge is that FDA conducts relatively few
inspections of foreign establishments; officials estimated that the
agency inspects foreign manufacturers of high-risk devices (such as
pacemakers) every 6 years and foreign manufacturers of medium-risk
devices (such as hearing aids) every 27 years. Finally, inspections of
foreign manufacturers pose unique challenges to FDA, such as
difficulties in recruiting investigators to travel to certain countries
and in extending trips if the inspections uncovered problems. FDA is
pursuing initiatives that could address some of these unique
challenges, but it is unclear whether FDA‘s proposals will increase the
frequency with which the agency inspects foreign establishments.
Few inspections of foreign medical device manufacturing establishments
have been conducted through FDA‘s two accredited third-party inspection
programs”the Accredited Persons Inspection Program and the Pilot Multi-
purpose Audit Program (PMAP). Under FDA‘s Accredited Persons Inspection
Program, from March 11, 2004”the date when FDA first cleared an
accredited organization to conduct independent inspections”through May
7, 2008, four inspections of foreign establishments had been conducted
by accredited organizations. An incentive to participation in the
program is the opportunity to reduce the number of inspections
conducted to meet FDA‘s and other countries‘ requirements.
Disincentives include bearing the cost for the inspection, particularly
when the consequences of an inspection that otherwise might not occur
in the near future could involve regulatory action. The Food and Drug
Administration Amendments Act of 2007 made several changes to program
eligibility requirements that could result in increased participation
by manufacturers. PMAP was established on September 7, 2006, as a
partnership between FDA and Canada‘s medical device regulatory agency
and allows accredited organizations to conduct a single inspection to
meet the regulatory requirements of both countries. As of May 7, 2008,
two inspections of foreign establishments had been conducted by
accredited organizations through this program. The small number of
inspections completed to date by accredited third-party organizations
raises questions about the practicality and effectiveness of these
programs to quickly help FDA increase the number of foreign
establishments inspected.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-780T]. For more
information, contact Marcia Crosse at (202) 512-7114 or
crossem@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you examine the Food and Drug
Administration's (FDA) program for inspecting foreign manufacturers of
medical devices for the U.S. market. FDA is responsible for the
regulation of medical devices[Footnote 1] marketed in the United
States, including those manufactured in foreign establishments.
[Footnote 2] FDA classifies medical devices into one of three classes
based on degree of potential risk and level of control needed to
reasonably ensure safety and effectiveness.[Footnote 3] According to
FDA data, a wide variety of class II (medium risk) and III (high risk)
medical devices may be manufactured for the U.S. market by foreign
establishments. Such devices include defibrillators, contact lenses,
pacemakers, hip prostheses, and coronary stents.[Footnote 4] FDA is
responsible for inspecting certain foreign and domestic establishments
to ensure they meet required manufacturing standards; such inspections
are FDA's primary means of assuring that the safety and effectiveness
of medical devices are not jeopardized by poor manufacturing practices.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
addressed concerns about FDA's ability to meet its responsibilities for
inspecting medical device manufacturing establishments.[Footnote 5]
MDUFMA included provisions designed to (1) increase the number of
inspected medical device manufacturing establishments and (2) help
medical device manufacturers meet the inspection requirements of both
the United States and foreign countries in a single inspection.
Specifically, MDUFMA required FDA to accredit third-party organizations
to conduct inspections of certain foreign and domestic establishments.
[Footnote 6] In response, FDA implemented its Accredited Persons
Inspection Program, which permits certain establishments to voluntarily
request inspections from third-party organizations to meet inspectional
requirements. In January 2007, we reported on the status of this
program citing, among other things, concerns regarding its
implementation and potential incentives and disincentives that may
influence manufacturers' participation.[Footnote 7] Additionally, in
partnership with Health Canada,[Footnote 8] FDA established in
September 2006 another program for inspection by accredited third
parties--the Pilot Multi-purpose Audit Program (PMAP)--that allows
accredited organizations to conduct a single inspection to meet the
regulatory requirements of both countries.
My remarks today are based primarily on our January 2008 statement,
which updated our January 2007 report, on FDA's management of its
medical device inspection program and our April 2008 statement on a
number of new FDA initiatives related to foreign inspections of FDA
regulated products, including medical devices.[Footnote 9] My remarks
will focus on our assessment of (1) FDA's program for inspecting
foreign establishments that manufacture medical devices for the U.S.
market and (2) FDA's programs for third-party inspections of foreign
medical device manufacturing establishments.
To address these objectives, we used work completed for our January
2008 statement on FDA's medical device inspection program, for which we
interviewed officials from FDA's Center for Devices and Radiological
Health (CDRH) and Office of Regulatory Affairs (ORA), which have
responsibilities for managing the medical device inspection program.
[Footnote 10] To assess FDA's program for inspecting foreign
establishments that manufacture medical devices, we obtained
information from FDA's Device Registration and Listing System (DRLS),
as of September 19, 2007; Field Accomplishments and Compliance Tracking
System (FACTS) for fiscal year 2002 through fiscal year 2007; and
Operational and Administrative System for Import Support (OASIS) for
fiscal year 2007. We assessed the reliability of these data by (1)
reviewing existing information about the data and the databases that
produced them, (2) interviewing agency officials knowledgeable about
the data, and (3) performing electronic testing of data elements from
DRLS and FACTS. We found the data in the FACTS database sufficiently
reliable for our purposes. We also found that DRLS was sufficiently
reliable, to the extent that it accurately reflects information
provided by foreign establishments that register to market medical
devices in the United States. However, we determined that these data do
not necessarily reflect the number of establishments that manufacture
medical devices for the U.S. market. In addition, we found that OASIS
is likely to overestimate the number of foreign establishments whose
medical devices have been imported into the United States because of
uncorrected errors in the data. Therefore, we present information from
both DRLS and OASIS to illustrate the variability in information that
FDA's databases provide on this topic. These data represent the best
information available and are what FDA relies on to manage its foreign
medical device inspection activities. In addition, in preparation for
our April 2008 statement, we obtained information from FDA officials to
learn about recent initiatives to improve the agency's program for
inspecting establishments manufacturing FDA-regulated products,
including medical devices. For today's statement, we obtained
additional data from FDA to update selected information from our
January 2008 statement.
To examine FDA's programs for third-party inspections of foreign
medical device manufacturing establishments, we updated work completed
for our January 2008 statement. We obtained FDA data on the number of
inspections conducted by accredited third parties from March 11, 2004-
-the date when FDA first cleared an accredited organization to conduct
inspections--through May 7, 2008. For our January 2008 statement, we
also obtained information from FDA about other critical aspects of its
programs for inspections by accredited third parties. To gain
perspective on recent changes to FDA's programs for inspections by
accredited third parties, we contacted representatives of the same 13
affected entities we interviewed for our January 2007 report on this
topic.[Footnote 11] We received responses from 2 of 4 accredited
organizations, 1 of 6 medical device manufacturers, and 2 of 3
organizations that represent medical device manufacturers. We shared
the facts contained in our current statement with FDA officials. FDA
provided technical comments, which are appropriately addressed in the
testimony. We conducted audit work for the January 2008 statement from
December 2007 to January 2008; for our April 2008 statement, from March
2008 through April 2008; and updated our work on medical devices in
early May 2008 for this statement. We conducted this work 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.
In summary, we found that FDA faces challenges in its program to
inspect foreign establishments manufacturing medical devices. In
January 2008, we testified that two databases that provide FDA with
information about foreign medical device establishments and the
products they manufacture for the U.S. market contained inaccurate
information about establishments subject to FDA inspection and could
not exchange information. Since then, FDA has made changes to its
registration process that could improve its database and provide the
agency with a more accurate count of foreign establishments that
manufacture medical devices. While the agency has initiated other steps
to improve its databases, it is too soon to know if these changes will
improve FDA's management of its foreign inspection program. Another
challenge is that FDA conducts relatively few inspections of foreign
establishments that manufacture medical devices. Officials estimated
the agency had inspected foreign class II manufacturers every 27 years
and foreign class III manufacturers every 6 years. Finally, inspections
of foreign medical device manufacturing establishments pose unique
challenges to FDA, such as difficulties in recruiting investigators to
voluntarily travel to certain countries and in extending trips if
problems are identified during inspections. FDA is pursuing initiatives
that could address some of these challenges, but it is unclear whether
the agency's proposals will increase the frequency with which FDA
inspects foreign establishments.
Few inspections of foreign medical device manufacturing establishments
have been conducted through FDA's two programs for inspections by
accredited third parties--the Accredited Persons Inspection Program and
PMAP. Under FDA's Accredited Persons Inspection Program, from March 11,
2004--the date when FDA first cleared an accredited organization to
conduct inspections--through May 7, 2008, four inspections of foreign
establishments had been conducted by accredited organizations. To
participate in this program, manufacturers must decide to request an
inspection by an accredited organization, and this decision might be
influenced by both potential incentives and disincentives. An incentive
to participation in the program is the opportunity to reduce the number
of inspections conducted to meet FDA and other countries' requirements.
Disincentives include bearing the cost for the inspection, particularly
when the consequences of an inspection that otherwise may not occur in
the near future could involve regulatory action. The Food and Drug
Administration Amendments Act of 2007 (FDAAA) changed the requirements
for inspections by accredited third parties in several ways, which
could result in increased participation by manufacturers, although it
is too soon to tell. For example, a requirement that foreign
establishments be periodically inspected by FDA before being eligible
for third-party inspections was eliminated. Device manufacturers may
also request an inspection by an accredited third party through PMAP,
which was established on September 7, 2006, and is limited to a
partnership with Canada. As of May 7, 2008, two inspections of foreign
establishments had been conducted by an accredited organization through
PMAP. The small number of inspections completed by accredited third-
party organizations raises questions about the practicality and
effectiveness of these programs to help FDA conduct additional foreign
inspections.
Background:
FDA is responsible for overseeing the safety and effectiveness of
medical devices that are marketed in the United States, whether
manufactured in domestic or foreign establishments. All establishments
that manufacture medical devices for marketing in the United States are
required to register annually with FDA.[Footnote 12] As part of its
efforts to ensure the safety, effectiveness, and quality of medical
devices, FDA is responsible for inspecting certain foreign and domestic
establishments to ensure that, among other things, they meet
manufacturing standards established in FDA's quality system
regulation.[Footnote 13] Within FDA, CDRH is responsible for assuring
the safety and effectiveness of medical devices. Among other things,
CDRH works with ORA, which conducts inspections of foreign
establishments. FDA may conduct inspections before and after medical
devices are approved or otherwise cleared to be marketed in the United
States.
* Premarket inspections are conducted before FDA approves U.S.
marketing of a new medical device that is not substantially equivalent
to one that is already on the market.[Footnote 14] Premarket
inspections primarily assess manufacturing facilities, methods, and
controls and may verify pertinent records.
* Postmarket inspections are conducted after a medical device has been
approved or otherwise cleared to be marketed in the United States and
include several types of inspections: (1) Quality system inspections
are conducted to assess compliance with applicable FDA regulations,
including the quality system regulation to ensure good manufacturing
practices and the regulation requiring reporting of adverse
events.[Footnote 15] These inspections may be comprehensive or
abbreviated, which differ in the scope of inspectional activity.
Comprehensive postmarket inspections assess multiple aspects of the
manufacturer's quality system, including management controls, design
controls, corrective and preventative actions, and production and
process controls. Abbreviated postmarket inspections assess only some
of these aspects, but always assess corrective and preventative
actions. (2) For-cause and compliance follow-up inspections are
initiated in response to specific information that raises questions or
problems associated with a particular establishment. (3) Postmarket
audit inspections are conducted within 8 to 12 months of a premarket
application's approval to examine any changes in the design,
manufacturing process, or quality assurance systems.
Requirements governing foreign and domestic inspections differ.
Specifically, FDA is required to inspect domestic establishments that
manufacture class II or III medical devices every 2 years.[Footnote 16]
There is no comparable requirement to inspect foreign establishments.
FDA does not have authority to require foreign establishments to allow
the agency to inspect their facilities. However, if an FDA request to
inspect is denied, FDA may prevent the importation of medical devices
from that foreign establishment into the United States. In addition,
FDA has the authority to conduct physical examinations of products
offered for import and, if there is sufficient evidence of a violation,
prevent their entry at the border.[Footnote 17] Unlike food, for which
FDA primarily relies on inspections at the border, physical inspection
of manufacturing establishments is a critical mechanism in FDA's
process to ensure that medical devices are safe and effective and that
manufacturers adhere to good manufacturing practices.
FDA determines which establishments to inspect using a risk-based
strategy. High priority inspections include premarket approval
inspections for class III devices, for-cause inspections, inspections
of establishments that have had a high frequency of device recalls, and
other devices and manufacturers FDA considers high risk. The
establishment's inspection history may also be considered. A provision
in FDAAA may assist FDA in making decisions about which establishments
to inspect because this law authorizes the agency to accept voluntary
submissions of audit reports addressing manufacturers' conformance with
internationally established standards for the purpose of setting risk-
based inspectional priorities.[Footnote 18]
FDA's programs for foreign and domestic inspections by accredited third
parties provide an alternative to the traditional FDA-conducted
comprehensive postmarket quality system inspection for eligible
manufacturers of class II and III medical devices. MDUFMA required FDA
to accredit third persons--which are organizations--to conduct
inspections of certain establishments. In describing this requirement,
the House of Representatives Committee on Energy and Commerce noted
that some manufacturers have faced an increase in the number of
inspections required by foreign countries and that the number of
inspections could be reduced if the manufacturers could contract with a
third-party organization to conduct a single inspection that would
satisfy the requirements of both FDA and foreign countries.[Footnote
19] Manufacturers that meet eligibility requirements may request a
postmarket inspection by an FDA-accredited organization.[Footnote 20]
The eligibility criteria for requesting an inspection of an
establishment by an accredited organization include that the
manufacturer markets a medical device in the United States and markets
(or intends to market) a medical device in at least one other country
and that the establishment to be inspected must not have received
warnings for significant deviations from compliance requirements on its
last inspection.[Footnote 21]
MDUFMA also established minimum requirements for organizations to be
accredited to conduct third-party inspections, including protections
against financial conflicts of interest and assurances of the
competence of the organization to conduct inspections. FDA developed a
training program for inspectors from accredited organizations that
involves both formal classroom training and completion of three joint
training inspections with FDA. Each individual inspector from an
accredited organization must complete all training requirements
successfully before being cleared to conduct independent inspections.
FDA relies on manufacturers to volunteer to host these joint
inspections, which count as FDA postmarket quality system inspections.
A manufacturer that is cleared to have an inspection by an accredited
third party enters an agreement with the approved accredited
organization and schedules an inspection. Once the accredited
organization completes its inspection, it prepares a report and submits
it to FDA, which makes the final assessment of compliance with
applicable requirements. FDAAA added a requirement that accredited
organizations notify FDA of any withdrawal, suspension, restriction, or
expiration of certificate of conformance with quality systems standards
(such as those established by the International Organization for
Standardization) for establishments they inspected for FDA.[Footnote
22]
In addition to the Accredited Persons Inspection Program, FDA has a
second program for accredited third-party inspections of medical device
establishments. On September 7, 2006, FDA and Health Canada announced
the establishment of PMAP. This pilot program was designed to allow
qualified third-party organizations to perform a single inspection that
would meet the regulatory requirements of both the United States and
Canada. The third-party organizations eligible to conduct inspections
through PMAP are those that FDA accredited for its Accredited Persons
Inspection Program (and that completed all required training for that
program) and that are also authorized to conduct inspections of medical
device establishments for Health Canada. To be eligible to have a third-
party inspection through PMAP, manufacturers must meet all criteria
established for the Accredited Persons Inspection Program. As with the
Accredited Persons Inspection Program, manufacturers must apply to
participate and be willing to pay an accredited organization to conduct
the inspection.
FDA relies on multiple databases to manage its program for inspecting
medical device manufacturing establishments.
* FDA's medical device registration and listing database contains
information on domestic and foreign medical device establishments that
have registered with FDA. Establishments that are involved in the
manufacture of medical devices intended for commercial distribution in
the United States are required to register annually with FDA. These
establishments provide information to FDA, such as an establishment's
name and its address and the medical devices it manufactures. Prior to
October 1, 2007, this information was maintained in DRLS. As of October
1, 2007, establishments are required to register electronically through
FDA's Unified Registration and Listing System and certain medical
device establishments pay an annual establishment registration fee,
which in fiscal year 2008 is $1,706.[Footnote 23]
* OASIS contains information on medical devices and other FDA-regulated
products imported into the United States, including information on the
establishment that manufactured the medical device. The information in
OASIS is automatically generated from data managed by Customs and
Border Protection (CBP). These data are originally entered by customs
brokers based on the information available from the importer.[Footnote
24] CBP specifies an algorithm by which customs brokers generate a
manufacturer identification number from information about an
establishment's name, address, and location.
* FACTS contains information on FDA's inspections, including those of
domestic and foreign medical device establishments. FDA investigators
enter information into FACTS following completion of an inspection.
According to FDA data, there are more registered establishments in
China and Germany reporting that they manufacture class II or III
medical devices than in any other foreign countries.[Footnote 25]
Canada and the United Kingdom also have a large number of registered
establishments.
FDA Faces Challenges Conducting Inspections of Foreign Establishments
That Manufacture Medical Devices:
FDA faces challenges in its program to inspect foreign establishments
manufacturing medical devices. The databases that provide FDA with data
about the number of foreign establishments manufacturing medical
devices for the U.S. market have not provided it with an accurate count
of foreign establishments for inspection. In addition, FDA conducted
relatively few inspections of foreign establishments. Moreover,
inspections of foreign medical device manufacturing establishments pose
unique challenges to FDA--both in human resources and logistics.
FDA Lacks Accurate Data on the Number of Foreign Establishments Subject
to Inspection, but Has Made Recent Attempts to Improve Its Data:
FDA's databases on registration and imported medical devices have not
provided an accurate count of establishments subject to inspection,
although recent improvements to FDA's medical device registration
database may address some weaknesses. In January 2008, we testified
that DRLS provided FDA with information about foreign medical device
establishments and the products they manufacture for the U.S. market.
According to DRLS, as of September 2007, 4,983 foreign establishments
that reported manufacturing a class II or III medical device for the
U.S. market had registered with FDA.[Footnote 26] However, these data
contained inaccuracies because establishments may register with FDA but
not actually manufacture a medical device or may manufacture a medical
device that is not marketed in the United States. In addition, FDA did
not routinely verify the data within this database.
Recent changes to FDA's medical device establishment registration
process could improve the accuracy of its database. In fiscal year
2008, FDA implemented, in addition to its annual user fee, electronic
registration and an active re-registration process for medical device
establishments.[Footnote 27] According to FDA, about half of previously
registered establishments had reregistered using the new system as of
April 11, 2008.[Footnote 28] While FDA officials expect that additional
establishments will reregister, they expect that the final result will
be the elimination of establishments that do not manufacture medical
devices for the U.S. market and thus a smaller, more accurate database
of medical device establishments. FDA officials indicated that
implementation of electronic registration and the annual user fee
seemed to have improved the data so FDA can more accurately identify
the type of establishment registered, the devices manufactured at an
establishment, and whether or not an establishment should be
registered. According to FDA officials, the revenue from device
registration user fees is applied to the process for the review of
device applications, including premarket inspections.[Footnote 29]
FDA has also proposed, but not yet implemented, the Foreign Vendor
Registration Verification Program, which could also help improve the
accuracy of information FDA maintains on registered foreign
establishments. Through this program, FDA plans to contract with an
external organization to conduct on-site verification of the
registration data and product listing information of foreign
establishments shipping medical devices and other FDA-regulated
products to the United States. FDA has solicited proposals for this
contract, but it is still developing the specifics of the program. For
example, as of April 2008, the agency had not yet established the
criteria it would use to determine which establishments would be
visited for verification purposes or determined how many establishments
it would verify annually. FDA plans to award this contract in June
2008. Given the early stages of this process, it is too soon to
determine whether this program will improve the accuracy of the data
FDA maintains on foreign medical device establishments.
FDA also obtains information on foreign establishments from OASIS,
which tracks the importation of medical devices and other FDA-regulated
products. While not intended to provide a count of establishments,
OASIS does contain information about the medical devices actually being
imported into the United States and the establishments manufacturing
them. However, inaccuracies in OASIS prevent FDA from using it to
develop a list of establishments subject to inspection. OASIS contains
an inaccurate count of foreign establishments manufacturing medical
devices imported into the United States as a result of unreliable
identification numbers generated by customs brokers when the product is
offered for entry.[Footnote 30] FDA officials told us that these errors
result in the creation of multiple records for a single establishment,
which results in inflated counts of establishments offering medical
devices for entry into the U.S. market. According to OASIS, in fiscal
year 2007, there were as many as 22,008 foreign establishments that
manufactured class II medical devices for the U.S. market and 3,575
foreign establishments that manufactured class III medical devices for
the U.S. market.[Footnote 31]
FDA has supported a proposal with the potential to address weaknesses
in OASIS, but FDA does not control the implementation of this proposed
change. FDA is pursuing the creation of a governmentwide unique
establishment identifier, as part of the Shared Establishment Data
Service (SEDS), to address these inaccuracies.[Footnote 32] Rather than
relying on the creation and entry of an identifier at the time of
import, SEDS would provide a unique establishment identifier and a
centralized service to provide commercially verified information about
establishments.[Footnote 33] The standard identifier would be submitted
as part of import entry data when required by FDA or other government
agencies. SEDS could thus eliminate the problems that have resulted in
multiple identifiers associated with an individual establishment. The
implementation of SEDS is dependent on action from multiple federal
agencies, including the integration of the concept into a CBP import
and export system under development and scheduled for implementation in
2010. In addition, once implemented by CBP, participating federal
agencies would be responsible for bearing the cost of integrating SEDS
with their own operations and systems. FDA officials are not aware of a
specific time line for the implementation of SEDS. Developing an
implementation plan for SEDS was recommended by the Interagency Working
Group on Import Safety.[Footnote 34]
Although comparing information from its registration and import
databases could help FDA determine the number of foreign establishments
marketing medical devices in the United States, the databases do not
exchange information to be compared electronically and any comparisons
are done manually. FDA is in the process of implementing additional
initiatives to improve the integration of its databases, and these
changes could make it easier for the agency to establish an accurate
count of foreign manufacturing establishments subject to inspection.
The agency's Mission Accomplishments and Regulatory Compliance Services
(MARCS) is intended to help FDA electronically integrate data from
multiple systems. It is specifically designed to give individual users
more complete information about establishments. FDA officials estimated
that MARCS, which is being implemented in stages, could be fully
implemented by 2011 or 2012. However, FDA officials told us that
implementation has been slow because the agency has been forced to
shift resources away from MARCS and toward the maintenance of current
systems that are still heavily used, such as FACTS and OASIS. Taken
together, changes to FDA's databases could provide the agency with more
accurate information on the number of establishments subject to
inspection. However, it is too early to tell whether this will improve
FDA's management of its inspection program.
FDA Inspects Relatively Few Foreign Medical Device Establishments:
From fiscal year 2002 through fiscal year 2007, FDA inspected
relatively few foreign medical device establishments and primarily
inspected establishments located in the United States. During this
period, FDA conducted an average of 247 foreign establishment
inspections each year, compared to 1,494 inspections of domestic
establishments.[Footnote 35] This average number of foreign inspections
suggests that each year FDA inspects about 6 percent of registered
foreign establishments that reported manufacturing class II or class
III medical devices.[Footnote 36] FDA officials estimated the agency
had inspected foreign class II manufacturers every 27 years and foreign
class III manufacturers every 6 years. The inspected foreign
establishments were in 44 foreign countries and more than two-thirds
were in 10 countries. Most of the countries with the highest number of
inspections were also among those with the largest number of registered
establishments that reported manufacturing class II or III medical
devices. The lowest rate of inspections in these 10 countries was in
China, where 64 inspections were conducted in this 6-year period and
568 establishments were registered as of May 6, 2008. (See table 1.)
Table 1: Number of FDA Inspections of Foreign Medical Device
Establishments, Fiscal Year 2002 through Fiscal Year 2007:
Country: Germany;
Number of inspections[A]: FY 2002: 39;
Number of inspections[A]: FY 2003: 30;
Number of inspections[A]: FY 2004: 34;
Number of inspections[A]: FY 2005: 51;
Number of inspections[A]: FY 2006: 25;
Number of inspections[A]: FY 2007: 52;
Number of inspections[A]: Total: 231;
Number of registered class II or III manufacturing establishments[B]:
460.
Country: United Kingdom;
Number of inspections[A]: FY 2002: 25;
Number of inspections[A]: FY 2003: 31;
Number of inspections[A]: FY 2004: 28;
Number of inspections[A]: FY 2005: 14;
Number of inspections[A]: FY 2006: 25;
Number of inspections[A]: FY 2007: 43;
Number of inspections[A]: Total: 166;
Number of registered class II or III manufacturing establishments[B]:
277.
Country: Canada;
Number of inspections[A]: FY 2002: 17;
Number of inspections[A]: FY 2003: 17;
Number of inspections[A]: FY 2004: 24;
Number of inspections[A]: FY 2005: 11;
Number of inspections[A]: FY 2006: 13;
Number of inspections[A]: FY 2007: 26;
Number of inspections[A]: Total: 108;
Number of registered class II or III manufacturing establishments[B]:
282.
Country: Japan;
Number of inspections[A]: FY 2002: 7;
Number of inspections[A]: FY 2003: 8;
Number of inspections[A]: FY 2004: 20;
Number of inspections[A]: FY 2005: 21;
Number of inspections[A]: FY 2006: 16;
Number of inspections[A]: FY 2007: 25;
Number of inspections[A]: Total: 97;
Number of registered class II or III manufacturing establishments[B]:
210.
Country: Ireland;
Number of inspections[A]: FY 2002: 15;
Number of inspections[A]: FY 2003: 22;
Number of inspections[A]: FY 2004: 13;
Number of inspections[A]: FY 2005: 13;
Number of inspections[A]: FY 2006: 16;
Number of inspections[A]: FY 2007: 11;
Number of inspections[A]: Total: 90;
Number of registered class II or III manufacturing establishments[B]:
62.
Country: France;
Number of inspections[A]: FY 2002: 16;
Number of inspections[A]: FY 2003: 14;
Number of inspections[A]: FY 2004: 17;
Number of inspections[A]: FY 2005: 14;
Number of inspections[A]: FY 2006: 12;
Number of inspections[A]: FY 2007: 10;
Number of inspections[A]: Total: 83;
Number of registered class II or III manufacturing establishments[B]:
154.
Country: Switzerland;
Number of inspections[A]: FY 2002: 6;
Number of inspections[A]: FY 2003: 12;
Number of inspections[A]: FY 2004: 19;
Number of inspections[A]: FY 2005: 9;
Number of inspections[A]: FY 2006: 7;
Number of inspections[A]: FY 2007: 18;
Number of inspections[A]: Total: 71;
Number of registered class II or III manufacturing establishments[B]:
108.
Country: China[C];
Number of inspections[A]: FY 2002: 0;
Number of inspections[A]: FY 2003: 0;
Number of inspections[A]: FY 2004: 21;
Number of inspections[A]: FY 2005: 19;
Number of inspections[A]: FY 2006: 11;
Number of inspections[A]: FY 2007: 13;
Number of inspections[A]: Total: 64;
Number of registered class II or III manufacturing establishments[B]:
568[D].
Country: Mexico;
Number of inspections[A]: FY 2002: 10;
Number of inspections[A]: FY 2003: 7;
Number of inspections[A]: FY 2004: 12;
Number of inspections[A]: FY 2005: 8;
Number of inspections[A]: FY 2006: 12;
Number of inspections[A]: FY 2007: 11;
Number of inspections[A]: Total: 60;
Number of registered class II or III manufacturing establishments[B]:
122.
Country: Italy;
Number of inspections[A]: FY 2002: 8;
Number of inspections[A]: FY 2003: 7;
Number of inspections[A]: FY 2004: 10;
Number of inspections[A]: FY 2005: 6;
Number of inspections[A]: FY 2006: 13;
Number of inspections[A]: FY 2007: 11;
Number of inspections[A]: Total: 55;
Number of registered class II or III manufacturing establishments[B]:
170.
Country: All other countries;
Number of inspections[A]: FY 2002: 66;
Number of inspections[A]: FY 2003: 83;
Number of inspections[A]: FY 2004: 102;
Number of inspections[A]: FY 2005: 67;
Number of inspections[A]: FY 2006: 69;
Number of inspections[A]: FY 2007: 69;
Number of inspections[A]: Total: 456;
Number of registered class II or III manufacturing establishments[B]:
1,871.
Country: Total;
Number of inspections[A]: FY 2002: 209;
Number of inspections[A]: FY 2003: 231;
Number of inspections[A]: FY 2004: 300;
Number of inspections[A]: FY 2005: 233;
Number of inspections[A]: FY 2006: 219;
Number of inspections[A]: FY 2007: 289;
Number of inspections[A]: Total: 1,481;
Number of registered class II or III manufacturing establishments[B]:
4,284.
Source: GAO analysis of FDA data.
[A] We were unable to differentiate inspections according to medical
device classification. FDA's inspection database contains the most
recent information available to FDA about the class of device
manufactured at the establishment and consequently does not contain
readily available information about the class of devices manufactured
at the time of a specific inspection. As a result, the data we present
include all inspections, regardless of the classification of the
manufactured device or devices. According to FDA officials, FDA
primarily conducts inspections of establishments manufacturing class II
or III medical devices.
[B] These counts represent the number of registered establishments as
of May 6, 2008.
[C] The inspection counts for China do not include inspections
conducted in Hong Kong or Taiwan because these inspections are tracked
separately in FACTS.
[D] Counts of registered establishments in China do not include
establishments registered in Hong Kong or Taiwan because these
establishments are tracked separately.
[End of table]
FDA's inspections of foreign medical device establishments were
primarily postmarket inspections. While premarket inspections were
generally FDA's highest priority, relatively few have had to be
performed in any given year.[Footnote 37] Therefore, FDA focused its
resources on postmarket inspections. From fiscal year 2002 through
fiscal year 2007, 89 percent of the 1,481 foreign establishment
inspections were for postmarket purposes.
FDA Faces Unique Challenges in Conducting Foreign Inspections:
Inspections of foreign establishments pose unique challenges to FDA--
both in human resources and logistics. FDA does not have a dedicated
cadre of investigators that only conduct foreign medical device
establishment inspections; those staff who inspect foreign
establishments also inspect domestic establishments. Among those
qualified to inspect foreign establishments,[Footnote 38] FDA relies on
staff to volunteer to conduct inspections. FDA officials told us that
it has been difficult to recruit investigators to voluntarily travel to
certain countries. However, they added that if the agency could not
find an individual to volunteer for a foreign inspection trip, it would
mandate the travel. Logistically, foreign medical device establishment
inspections are difficult to extend even if problems are identified
because the trips are scheduled in advance.[Footnote 39] Foreign
medical device establishment inspections are also logistically
challenging because investigators do not receive independent
translational support from FDA or the State Department and may rely on
English-speaking employees of the inspected establishment or the
establishment's U.S. agent to translate during an inspection.
FDA recently announced proposals to address some of the challenges
unique to conducting foreign inspections, but specific steps toward
implementation and associated time frames are unclear. FDA noted in its
report on revitalizing ORA that it was exploring the creation of a
cadre of investigators who would be dedicated to conducting foreign
inspections.[Footnote 40] However, the report did not provide any
additional details or time frames about this proposal. In addition, FDA
announced plans to establish a permanent presence overseas, although
little information about these plans is available. FDA intends that its
foreign offices will improve cooperation and information exchange with
foreign regulatory bodies, improve procedures for expanded inspections,
allow it to inspect facilities quickly in an emergency, and facilitate
work with private and government agencies to assure standards for
quality. FDA's proposed foreign offices are intended to expand the
agency's capacity for overseeing, among other things, medical devices,
drugs, and food that may be imported into the United States. The extent
to which the activities conducted by foreign offices are relevant to
FDA's foreign medical device inspection program is uncertain.
Initially, FDA plans to establish a foreign office in China with three
locations--Beijing, Shanghai, and Guangzhou--comprised of a total of
eight FDA employees and five Chinese nationals. The Beijing office,
which the agency expects will be partially staffed by the end of 2008,
will be responsible for coordination between FDA and Chinese regulatory
agencies. FDA staff located in Shanghai and Guangzhou, who are to be
hired in 2009, will be focused on conducting inspections and working
with Chinese inspectors to provide training as necessary. FDA noted
that the Chinese nationals will primarily provide support to FDA staff,
including translation and interpretation. The agency is also
considering setting up offices in other locations, such as India, the
Middle East, Latin America, and Europe, but no dates have been
specified. While the establishment of both a foreign inspection cadre
and offices overseas have the potential for improving FDA's oversight
of foreign establishments, it is too early to tell whether these steps
will be effective or will increase the number of foreign medical device
establishment inspections.
Few Inspections of Foreign Establishments Have Been Conducted Through
FDA's Third-Party Programs, but Recent Changes Could Eliminate Some
Obstacles to Manufacturers' Participation:
Few inspections of foreign medical device manufacturing establishments-
-a total of six--have been conducted through FDA's two accredited third-
party inspection programs, the Accredited Persons Inspection Program
and PMAP. FDAAA specified several changes to the requirements for
inspections by accredited third parties that could result in increased
participation by manufacturers.
Few inspections have been conducted through FDA's Accredited Persons
Inspection Program since March 11, 2004--the date when FDA first
cleared an accredited organization to conduct independent inspections.
Through May 7, 2008, four inspections of foreign establishments had
been conducted independently by accredited organizations.[Footnote 41]
As of May 7, 2008, 16 third-party organizations were accredited, and
individuals from 8 of these organizations had completed FDA's training
requirements and been cleared to conduct independent
inspections.[Footnote 42] FDA and accredited organizations had
conducted 44 joint training inspections. As we previously reported,
fewer manufacturers volunteered to host training inspections than have
been needed for all of the accredited organizations to complete their
training,[Footnote 43] and scheduling these joint training inspections
has been difficult. FDA officials told us that, when appropriate, staff
are instructed to ask manufacturers to host a joint training inspection
at the time they notify the manufacturers of a pending inspection. FDA
schedules inspections a relatively short time prior to an actual
inspection,[Footnote 44] and as we previously reported, some accredited
organizations have not been able to participate because they had prior
commitments.
We previously reported that manufacturers' decisions to request an
inspection by an accredited organization might be influenced by both
potential incentives and disincentives. According to FDA officials and
representatives of affected entities, potential incentives to
participation include the opportunity to reduce the number of
inspections conducted to meet FDA and other countries' requirements.
For example, one inspection conducted by an accredited organization was
a single inspection designed to meet the requirements of FDA, the
European Union, and Canada. Another potential incentive mentioned by
FDA officials and representatives of affected entities is the
opportunity to control the scheduling of the inspection by an
accredited organization by working with the accredited organization.
FDA officials and representatives of affected entities also mentioned
potential disincentives to having an inspection by an accredited
organization. These potential disincentives include bearing the cost
for the inspection,[Footnote 45] doubts about whether accredited
organizations can cover multiple requirements in a single inspection,
and uncertainty about the potential consequences of an inspection that
otherwise may not occur in the near future--consequences that could
involve regulatory action.
Changes specified by FDAAA have the potential to eliminate certain
obstacles to manufacturers' participation in FDA's programs for
inspections by accredited third parties that were associated with
manufacturers' eligibility. For example, a requirement that foreign
establishments be periodically inspected by FDA before being eligible
for third-party inspections was eliminated. Representatives of the two
organizations that represent medical device manufacturers with whom we
spoke about FDAAA told us that the changes in eligibility requirements
could eliminate certain obstacles and therefore potentially increase
manufacturers' participation. These representatives also noted that key
incentives and disincentives to manufacturers' participation remain.
FDA officials told us that they were revising their guidance to
industry in light of FDAAA and expected to issue the revised guidance
during fiscal year 2008.[Footnote 46] It is too soon to tell what
impact these changes will have on manufacturers' participation.
FDA officials have acknowledged that manufacturers' participation in
the Accredited Persons Inspection Program has been limited. In December
2007, FDA established a working group to assess the successes and
failures of this program and to identify ways to increase
participation. Representatives of two organizations that represent
medical device manufacturers told us that they believe manufacturers
remain interested in the Accredited Persons Inspection Program. The
representative of one large, global manufacturer of medical devices
told us that it was in the process of arranging to have 20 of its
domestic and foreign device manufacturing establishments inspected by
accredited third parties.
As of May 7, 2008, two inspections of foreign establishments had been
conducted through PMAP,[Footnote 47] FDA's second program for
inspections by accredited third parties. Although it is too soon to
tell what the benefits of PMAP will be, the program is more limited
than the Accredited Persons Inspection Program and may pose additional
disincentives to participation by both manufacturers and accredited
organizations. Specifically, inspections through PMAP would be designed
to meet the requirements of the United States and Canada, whereas
inspections conducted through the Accredited Persons Inspection Program
could be designed to meet the requirements of other countries. In
addition, two of the five representatives of affected entities whom we
spoke to for our January 2008 statement noted that in contrast to
inspections conducted through the Accredited Persons Inspection
Program, inspections conducted through PMAP could undergo additional
review by Health Canada. Health Canada will review inspection reports
submitted through this pilot program to ensure the inspections meet its
standards. This extra review poses a greater risk of unexpected
outcomes for the manufacturer and the accredited organization, which
could be a disincentive to participation in PMAP that is not present
with the Accredited Persons Inspection Program.
Concluding Observations:
Americans depend on FDA to ensure the safety and effectiveness of
medical devices manufactured throughout the world. A variety of medical
devices are manufactured in other countries, including high-risk
devices designed to be implanted or used in invasive procedures.
However, FDA faces challenges in inspecting foreign establishments.
Weaknesses in its database prevent it from accurately identifying
foreign establishments manufacturing medical devices for the United
States and prioritizing those establishments for inspection. In
addition, staffing and logistical difficulties associated with foreign
inspections complicate FDA's ability to conduct such inspections. The
agency has recently taken some positive steps to improve its foreign
inspection program, such as initiating changes to improve the accuracy
of the data it uses to manage this program and announcing plans to
increase its presence overseas. However, it is too early to tell
whether these steps will ultimately enhance the agency's ability to
select establishments to inspect and increase the number of foreign
establishments inspected. To date, FDA's programs for inspections by
accredited third parties have not assisted FDA in meeting its
regulatory responsibilities nor have these programs provided a rapid or
substantial increase in the number of inspections performed by these
organizations, as originally intended. Recent statutory changes to the
requirements for inspections by accredited third parties may encourage
greater participation in these programs. However, the lack of
meaningful progress in conducting inspections to this point raises
questions about the practicality and effectiveness of these programs to
help FDA conduct additional foreign inspections.
Mr. Chairman, this completes my prepared statement. I would be happy to
respond to any questions you or the other Members of the subcommittee
may have at this time.
Contacts and Acknowledgments:
For further information about this statement, please contact Marcia
Crosse at (202) 512-7114 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may found on the
last page of this statement. Geraldine Redican-Bigott, Assistant
Director; Kristen Joan Anderson; Katherine Clark; William Hadley;
Cathleen Hamann; Julian Klazkin; and Lisa Motley made key contributions
to this statement.
[End of testimony]
Footnotes:
[1] Medical devices include instruments, apparatuses, machines, and
implants that are intended for use to diagnose, cure, treat, or prevent
disease, or to affect the structure or any function of the body. 21
U.S.C. § 321(h).
[2] FDA regulations define an establishment as a place of business
under one management at one general physical location at which a device
is manufactured, assembled, or otherwise processed. 21 C.F.R. §
807.3(c) (2007). Medical device manufacturers may have more than one
establishment. We use the term "manufacture" to refer to activities
including manufacturing, preparing, and processing devices.
[3] 21 U.S.C. § 360c. Medical devices are classified into one of three
classes. Class I includes "low risk" devices, such as tongue
depressors, elastic bandages, and bedpans. Class II includes "medium
risk" devices, such as syringes, hearing aids, and electrocardiograph
machines. Class III includes "high risk" devices, such as heart valves,
pacemakers, and defibrillators.
[4] A coronary stent is a small tube that is placed within a coronary
artery to keep the vessel open.
[5] See Pub. L. No. 107-250, § 201, 116 Stat. 1588, 1602-09 (2002)
(codified as amended at 21 U.S.C. § 374(g)).
[6] In this report, unless otherwise noted, when we discuss
inspections, we are referring to those conducted by FDA investigators.
[7] GAO, Medical Devices: Status of FDA's Program for Inspections by
Accredited Organizations, [hyperlink,
http://www.gao.gov/cgi-bin/getrpt?GAO-07-157] (Washington, D.C.: Jan. 5, 2007).
[8] Health Canada is the governmental entity that regulates medical
devices marketed in Canada.
[9] GAO, Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections, [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-428T]
(Washington, D.C.: Jan. 29, 2008) and GAO, Drug Safety: Preliminary
Findings Suggest Recent FDA Initiatives Have Potential, but Do Not
Fully Address Weaknesses in Its Foreign Drug Inspection Program,
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-701T]
(Washington, D.C.: Apr. 22, 2008).
[10] Within FDA, the Center for Biologics Evaluation and Research
regulates medical devices involved in human immunodeficiency virus
(HIV) testing and the collection, processing, testing, manufacture, and
administration of licensed blood, blood components, and cellular
products. We did not include medical devices regulated by this center
in the scope of our work.
[11] These affected entities included accredited organizations,
organizations that represent medical device manufacturers, and medical
device manufacturers.
[12] 21 U.S.C. § 360(b), (i).
[13] 21 C.F.R. pt. 820 (2007). The quality system regulation requires,
among other things, that domestic or foreign manufacturers have a
quality system in place to implement current good manufacturing
practices in the design, manufacture, packaging, labeling, storage,
installation, and servicing of finished medical devices intended for
human use in the United States. A quality system includes the
organizational structure, responsibilities, procedures, processes, and
resources for implementing quality management.
[14] Currently, most medical devices are cleared for marketing in the
United States because they are determined to be "substantially
equivalent" to a marketed device. FDA generally does not conduct
premarket inspections of establishments manufacturing these types of
medical devices.
[15] 21 C.F.R. pt. 803 (2007).
[16] 21 U.S.C. § 360(h). There is no statutory requirement for
inspection of class I medical device manufacturing establishments, and
FDA does not routinely inspect them. However, FDA periodically inspects
establishments manufacturing surgeon's gloves and patient examination
gloves, which are both class I medical devices, due to ongoing problems
with leakage. FDA also periodically inspects manufacturers of randomly
selected class I devices.
[17] 21 U.S.C. § 381(a); 21 C.F.R. § 820.1(d) (2007).
[18] Pub. L. No. 110-85, § 228, 121 Stat. 823, 858 (2007).
[19] H.R. Rep. No. 107-728, pt. 1, at 32-36 (2002). Some foreign
countries have accredited, certified, or otherwise recognized
organizations to conduct inspections. We use the term "single
inspection" to mean a complete inspection that covers all requirements
of two or more countries, without repeating those activities covered
under more than one set of requirements. A complete inspection can be
conducted during a single block of time or in multiple phases. Two or
more separate inspection reports could be generated on the basis of
that single inspection.
[20] Accredited organizations may conduct comprehensive postmarket
quality system inspections, but not other types of inspections of
establishments that FDA has the authority to conduct, such as premarket
or for-cause inspections. FDA may conduct its own inspections of
establishments even after inspection by an accredited organization.
[21] See 21 U.S.C. § 374(g)(6). FDAAA eliminated certain previously
established eligibility requirements. For example, it eliminated a
limitation on the number of consecutive inspections allowed by an
accredited organization and a limitation that foreign establishments
must be inspected periodically by FDA.
[22] 21 U.S.C. § 374(g)(3)(F).
[23] 21 U.S.C. §§ 360(i)(1), (p), 379i(13), 379j(a)(3), (b), (h). The
registration user fee will increase by 8.5 percent per year, to $2,364
in fiscal year 2012. Fees are available for obligation only to the
extent and in the amount provided in advance in annual appropriations
acts. FDA's authority to assess registration fees terminates on October
1, 2012. Pub. L. No. 110-85, § 217; 121 Stat. 823, 852 (2007).
[24] Customs brokers are private individuals, partnerships,
associations, or corporations licensed, regulated, and empowered by CBP
to assist in meeting federal requirements governing imports and
exports.
[25] Counts of registered establishments in China do not include
establishments registered in Hong Kong or Taiwan as these
establishments are tracked separately.
[26] DRLS contained one additional registered establishment for which
location information was not available.
[27] FDA indicated that it will deactivate the registrations of those
establishments that fail to complete the annual registration. Officials
noted that many establishments that had previously registered had not
updated those registrations in several years.
[28] According to FDA, the agency sent letters on April 11, 2008 and
April 14, 2008 to establishments that had registered in the past but
had not completed their registration for fiscal year 2008 advising them
that they must register using the new system and must pay the
registration fee, if applicable, to be considered registered.
Establishments that do not reregister within a month of those letters
would be considered inactive. As of May 6, 2008, prior to the mid-May
deadline, FDA reported that 4,284 registered foreign establishments
reported that they manufacture class II or class III medical devices.
This total also includes some establishments that may not reregister.
[29] See 21 U.S.C. §§ 379i(8), 379j(h)(1), (2).
[30] The algorithm currently used by customs brokers to assign the
manufacturer identification number does not provide for a number that
is reliably reproduced or inherently unique.
[31] According to FDA officials, a single establishment could be
manufacturing more than one class of device.
[32] The SEDS concept was developed by a working group with
representatives from FDA, the Environmental Protection Agency, and the
departments of Agriculture, Commerce, Defense, and Homeland Security.
[33] If an establishment did not already have an identification number,
it would request an identification number through SEDS, which would
verify the data about the establishment through a commercial service.
This commercial service would provide researched and validated records
on domestic and foreign establishments.
[34] Interagency Working Group on Import Safety, Action Plan for Import
Safety: A Roadmap for Continual Improvement (Nov. 2007) [hyperlink,
http://www.importsafety.gov/report/actionplan.pdf], accessed May 6,
2008).
[35] We were unable to differentiate inspections according to medical
device classification. FDA's inspection database contains the most
recent information available to FDA about the class of device
manufactured at the establishment and consequently does not contain
readily available information about the class of devices manufactured
at the time of a specific inspection. As a result, the data we present
include all inspections, regardless of the classification of the
manufactured device or devices. According to FDA officials, FDA
primarily conducts inspections of establishments manufacturing class II
or III medical devices.
[36] This calculation is based on the 4,284 registered establishments
that reported that they manufacture class II or III medical devices, as
of May 6, 2008.
[37] Currently, most medical devices are cleared for marketing in the
United States because they are determined to be "substantially
equivalent" to a marketed device. FDA generally does not conduct
premarket inspections of establishments manufacturing these types of
medical devices.
[38] Staff members must meet certain criteria in terms of their
experience and training to conduct inspections of foreign
establishments. For example, they are required to take certain training
courses and have at least 3 years of experience conducting domestic
inspections before they can be considered qualified to conduct a
foreign inspection.
[39] Typically, FDA investigators travel abroad for about 3 weeks at a
time, during which they inspect approximately three establishments.
[40] See, for example, Food and Drug Administration, Revitalizing ORA:
Protecting the Public Health Together In a Changing World (Rockville,
Md.: January 2008).
[41] Two inspections of domestic establishments were also conducted
through FDA's Accredited Persons Inspection Program.
[42] Specific foreign jurisdictions that have certified, accredited, or
otherwise recognized one or more of the FDA-accredited organizations
that have been cleared to conduct independent inspections include all
member states of the European Community, Australia, Canada, New
Zealand, Norway, Taiwan, and the United Kingdom. Of the eight third-
party organizations that have been cleared to conduct independent
inspections through the Accredited Persons Inspection Program, four may
conduct inspections through PMAP.
[43] As we reported in January 2007, some representatives of affected
entities speculated that manufacturers might not have volunteered to
host training inspections because they believed that training
inspections would require more time and effort for their staff (and
would thus be more disruptive) than inspections conducted by fully
trained personnel, or that manufacturers might have believed that
training inspections would be more rigorous than nontraining
inspections if the trainees and FDA personnel were to take particular
care to demonstrate their thoroughness to each other.
[44] FDA generally notifies manufacturers about a week in advance of
postmarket quality system inspections of domestic establishments and
about 6 to 8 weeks in advance of postmarket quality system inspections
of foreign establishments.
[45] In January 2007, we reported that representatives of accredited
organizations indicated that the cost to manufacturers would vary
depending on such factors as the size of the manufacturer and how much
extra time would be required to assess compliance with FDA
requirements. Representatives suggested that covering FDA's
requirements could take 2 or more days in addition to the time spent
assessing other countries' requirements, plus time for advance
preparation and writing the inspection report. They speculated that
they would probably charge manufacturers from $1,700 to $2,500 per day,
plus the cost of travel and living expenses.
[46] As of May 6, 2008, this guidance had not been issued.
[47] Three inspections of domestic establishments were conducted
through PMAP.
[End of section]
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(202) 512-4400:
U.S. Government Accountability Office:
441 G Street NW, Room 7125:
Washington, D.C. 20548:
Public Affairs:
Chuck Young, Managing Director, youngc1@gao.gov:
(202) 512-4800:
U.S. Government Accountability Office:
441 G Street NW, Room 7149:
Washington, D.C. 20548:
