Medical Devices
Status of FDA's Program for Inspections by Accredited Organizations Gao ID: GAO-07-157 January 5, 2007The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers.
FDA granted accreditation to 17 of 23 organizations that applied to conduct inspections of establishments where medical devices are manufactured. FDA denied accreditation to applicants that did not meet minimum criteria because their applications were not correctly completed or did not demonstrate the applicants' technical competence. During the first accreditation year, which started in April 2003, FDA received 23 applications. Of the 23 applications, 2 were not correctly completed and 2 did not demonstrate that the applicants had adequate technical competence. Although the remaining 19 applicants met the minimum criteria, MDUFMA limited the number of organizations that could be accredited to 15 during the first year after FDA issued criteria for accreditation. FDA scored the 19 applications against these criteria and rank-ordered them. It accredited the 15 organizations with the highest ranking applications, but 1 organization later withdrew. After the initial accreditation year, FDA received 2 more applications for accreditation and it accredited both organizations. These 16 organizations remained accredited as of October 31, 2006. Between March 11, 2004, and October 31, 2006, two accredited organizations conducted independent inspections--one inspection of a domestic establishment and one inspection of a foreign establishment. During that same period, 36 inspections of domestic establishments and 1 inspection of a foreign establishment were conducted by accredited organizations jointly with FDA officials as part of training that FDA requires of accredited organizations. As of October 31, 2006, individuals from 7 of the 16 accredited organizations had completed all training requirements and were cleared to conduct independent inspections. Several factors may influence manufacturers' interest in voluntarily requesting an inspection by an accredited organization. According to FDA and representatives of affected entities, there are potential incentives and disincentives to requesting an inspection, as well as reasons for deferring participation in the program. Potential incentives include the opportunity to reduce the number of inspections conducted to meet FDA and other countries' requirements and to control the scheduling of the inspection. Potential disincentives include bearing the cost for the inspection and uncertainty about the potential consequences of making a commitment to having an inspection to assess compliance with FDA requirements in the near future. Some manufacturers might be deferring participation. For example, manufacturers that already contract with a specific accredited organization to conduct inspections to meet the requirements of other countries might defer participation until FDA has cleared that organization to conduct independent inspections. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.
GAO-07-157, Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations
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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
January 2007:
Medical Devices:
Status of FDA's Program for Inspections by Accredited Organizations:
Inspections by Accredited Organizations:
GAO-07-157:
GAO Highlights:
Highlights of GAO-07-157, a report to congressional committees
Why GAO Did This Study:
The Food and Drug Administration (FDA) inspects domestic and foreign
establishments where U.S.-marketed medical devices are manufactured to
assess compliance with FDA‘s quality system requirements for ensuring
good manufacturing practices and other applicable requirements. The
Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required
FDA to accredit organizations to inspect certain establishments where
devices that are marketed in both the United States and other countries
are manufactured.
This report includes information that MDUFMA requires GAO to provide on
(1) the number of organizations that sought accreditation, the number
that were accredited, and reasons for denial of accreditation and (2)
the number of inspections conducted by accredited organizations. It
also includes information about factors that could influence
manufacturers‘ interest in voluntarily requesting and paying for an
inspection by an accredited organization.
GAO examined FDA documents, interviewed FDA officials, and obtained
information from FDA on the number of inspections conducted from March
11, 2004”when FDA first cleared an accredited organization to conduct
independent inspections”through October 31, 2006. GAO also interviewed
affected entities, including accredited organizations and medical
device manufacturers.
What GAO Found:
FDA granted accreditation to 17 of 23 organizations that applied to
conduct inspections of establishments where medical devices are
manufactured. FDA denied accreditation to applicants that did not meet
minimum criteria because their applications were not correctly
completed or did not demonstrate the applicants‘ technical competence.
During the first accreditation year, which started in April 2003, FDA
received 23 applications. Of the 23 applications, 2 were not correctly
completed and 2 did not demonstrate that the applicants had adequate
technical competence. Although the remaining 19 applicants met the
minimum criteria, MDUFMA limited the number of organizations that could
be accredited to 15 during the first year after FDA issued criteria for
accreditation. FDA scored the 19 applications against these criteria
and rank-ordered them. It accredited the 15 organizations with the
highest ranking applications, but 1 organization later withdrew. After
the initial accreditation year, FDA received 2 more applications for
accreditation and it accredited both organizations. These 16
organizations remained accredited as of October 31, 2006.
Between March 11, 2004, and October 31, 2006, two accredited
organizations conducted independent inspections”one inspection of a
domestic establishment and one inspection of a foreign establishment.
During that same period, 36 inspections of domestic establishments and
1 inspection of a foreign establishment were conducted by accredited
organizations jointly with FDA officials as part of training that FDA
requires of accredited organizations. As of October 31, 2006,
individuals from 7 of the 16 accredited organizations had completed all
training requirements and were cleared to conduct independent
inspections.
Several factors may influence manufacturers‘ interest in voluntarily
requesting an inspection by an accredited organization. According to
FDA and representatives of affected entities, there are potential
incentives and disincentives to requesting an inspection, as well as
reasons for deferring participation in the program. Potential
incentives include the opportunity to reduce the number of inspections
conducted to meet FDA and other countries‘ requirements and to control
the scheduling of the inspection. Potential disincentives include
bearing the cost for the inspection and uncertainty about the potential
consequences of making a commitment to having an inspection to assess
compliance with FDA requirements in the near future. Some manufacturers
might be deferring participation. For example, manufacturers that
already contract with a specific accredited organization to conduct
inspections to meet the requirements of other countries might defer
participation until FDA has cleared that organization to conduct
independent inspections.
The Department of Health and Human Services provided technical comments
on a draft of this report, which GAO incorporated as appropriate.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-157].
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119 or crossem@gao.gov.
[End of Section]
Contents:
Letter:
Results in Brief:
Background:
FDA Accredited 17 of 23 Organizations and Denied Accreditation When
Criteria Were Not Met or Because MDUFMA Limited the Number That Could
Be Accredited:
Two Inspections Independently Conducted by an Accredited Organization:
Several Factors Could Influence Manufacturers' Interest in
Participating in the Program:
Agency Comments:
Appendix I: Inspections Conducted by the Food and Drug Administration:
Appendix II: Scope and Methodology:
Appendix III: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Dates on Which FDA Cleared Accredited Organizations to Conduct
Independent Inspections:
Table 2: Affected Entities with Which We Conducted Interviews:
Abbreviations:
FDA: Food and Drug Administration:
GMP: good manufacturing practices:
MDUFMA: Medical Device User Fee and Modernization Act of 2002:
United States Government Accountability Office:
Washington, DC 20548:
January 5, 2007:
The Honorable Edward M. Kennedy:
Chairman:
The Honorable Michael B. Enzi:
Ranking Minority Member:
Committee on Health, Education, Labor and Pensions:
United States Senate:
The Honorable John D. Dingell:
Chairman:
The Honorable Joe Barton:
Ranking Minority Member:
Committee on Energy and Commerce:
House of Representatives:
The Food and Drug Administration (FDA) is responsible for regulating
medical devices that are marketed in the United States.[Footnote 1] As
part of its responsibilities, FDA inspects domestic and foreign
establishments[Footnote 2] where medical devices that are marketed in
the United States are manufactured[Footnote 3] to assess compliance
with FDA's quality system requirements[Footnote 4] for ensuring good
manufacturing practices (GMP) and other applicable requirements. During
quality system inspections, FDA investigators examine manufacturing
controls, processes, and records. These inspections are FDA's primary
means of assuring that the safety and effectiveness of medical devices
are not jeopardized by poor manufacturing practices. FDA is required,
by statute, to inspect certain domestic establishments where medical
devices are manufactured at least once every 2 years.[Footnote 5] FDA
has not, however, been meeting this requirement. Instead, 5 or 6 years
sometimes pass between FDA inspections at any one establishment. In
addition to FDA inspections, many foreign countries require inspections
of establishments where medical devices are manufactured. As a result,
manufacturers that market their devices internationally may face
multiple inspections of their establishments to assess conformity with
quality system requirements of multiple regulatory authorities. Some
foreign countries have accredited, certified, or otherwise recognized
organizations to conduct inspections.
In 2002, the U.S. House of Representatives Committee on Energy and
Commerce recognized that the growth of the medical device industry,
combined with resource constraints at FDA, had made it difficult for
FDA to meets its obligation to inspect, every 2 years, domestic
establishments where class II and class III medical devices are
manufactured.[Footnote 6] It also 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 one of these recognized organizations
to conduct a single inspection that would satisfy the requirements of
both the FDA and foreign countries.[Footnote 7] The Medical Device User
Fee and Modernization Act of 2002 (MDUFMA), enacted in October 2002,
included provisions designed to (1) increase the number of medical
device manufacturers' establishments that are inspected for compliance
with FDA requirements and (2) help manufacturers who market medical
devices in both the United States and foreign countries meet multiple
inspection requirements with fewer inspections.[Footnote 8]
Specifically, MDUFMA, as amended by the Medical Devices Technical
Corrections Act,[Footnote 9] required FDA to accredit persons--which
are organizations--to conduct inspections of certain establishments. In
response, FDA implemented an accredited persons inspection program,
which provides an alternative to a traditional FDA-conducted postmarket
inspection for eligible manufacturers of medical devices who apply to
participate and are willing to pay an accredited organization to
conduct the inspection.[Footnote 10] (FDA conducts inspections at no
cost to the manufacturer.) Under this program, organizations accredited
by FDA may inspect establishments and submit reports to FDA, which
makes the final determination of compliance with applicable laws and
regulations. MDUFMA specified eligibility criteria for manufacturers to
participate in the program, including that the manufacturer markets, or
intends to market, a medical device in a foreign country, and that the
establishment did not receive warnings for significant deviations from
compliance requirements based on its last inspection.[Footnote 11]
MDUFMA also established minimum requirements for organizations to be
accredited to conduct inspections through this program, including
protecting against financial conflicts of interest and ensuring the
competence of the organization to conduct inspections. MDUFMA required
FDA to issue criteria for accreditation within 180 days of its
enactment, and limited the number of organizations that FDA could
accredit during the first year after issuance of criteria for
accreditation to 15.[Footnote 12]
MDUFMA requires us to report on several aspects of FDA's accredited
persons inspection program.[Footnote 13] This report provides
information on the status of the program, specifically, (1) the number
of organizations that sought accreditation, the number that were
accredited, and reasons for denial of accreditation and (2) the number
of inspections conducted by accredited organizations. This report also
provides information about factors that could influence manufacturers'
interest in voluntarily participating in FDA's accredited persons
inspection program. In addition, MDUFMA also requires us to report on
the number of inspections conducted by FDA; this information is
included in appendix I. MDUFMA also requires us to report on other
aspects related to the oversight and effectiveness of the accredited
persons inspection program, but data were too limited for us to provide
meaningful information on these aspects of the program at this time.
To conduct our review, we examined FDA documentation of the number of
applications for accreditation it received and its evaluation of those
applications, and we interviewed FDA officials. We also asked FDA to
provide the number of inspections conducted from March 11, 2004--the
date when FDA first cleared an accredited organization to conduct
independent inspections--through October 31, 2006. We determined that
the data FDA provided were sufficiently reliable for the purposes of
this report. To gain perspective on manufacturers' interest in
participating in the accredited persons inspection program, we
interviewed representatives of FDA and affected entities--four
accredited organizations, three organizations that represent
manufacturers, and six manufacturers. The information we obtained from
this nonscientific sample of representatives of affected entities can
not be generalized to other accredited organizations or manufacturers.
We conducted our work from February 2006 through November 2006 in
accordance with generally accepted government auditing standards. See
appendix II for a more detailed discussion of our methodology.
Results in Brief:
FDA granted accreditation to 17 of 23 organizations that applied to
conduct inspections of establishments. FDA denied accreditation to
applicants that did not meet minimum criteria because their
applications were not correctly completed or did not demonstrate the
applicants' technical competence. During the first accreditation year-
-which started in April 2003--FDA received 23 applications. Of the 23
applications, 2 were not correctly completed and 2 did not demonstrate
that the applicants had adequate technical competence. Although the
remaining 19 applicants met the minimum criteria, MDUFMA limited the
number of organizations that could be accredited to 15 during the first
year after FDA issued criteria for accreditation. FDA scored the 19
applications against these criteria and rank-ordered them. It
accredited the 15 organizations with the highest ranking applications,
but 1 organization later withdrew. After the initial accreditation
year, FDA received 2 additional applications for accreditation and it
accredited both organizations. These 16 organizations remained
accredited as of October 31, 2006.
Between March 11, 2004, and October 31, 2006, two accredited
organizations conducted independent inspections--one inspection of a
domestic establishment and one inspection of a foreign establishment.
During this same time period, 36 inspections of domestic establishments
and 1 inspection of a foreign establishment were conducted by
accredited organizations jointly with FDA officials as part of the
training FDA requires of accredited organizations. As of October 31,
2006, individuals from 7 of the 16 accredited organizations had
completed all training requirements and were cleared to conduct
independent inspections. The remaining 9 accredited organizations had
not completed all training requirements by that date.
Several factors may influence manufacturers' interest in voluntarily
participating in the accredited persons inspection program, either by
requesting an inspection or by hosting a training inspection. According
to FDA and representatives of affected entities, factors that might
influence manufacturers' decisions to request an inspection by an
accredited organization include (a) potential incentives, (b) potential
disincentives, and (c) reasons for deferring participation in the
inspection program. Potential incentives include the opportunity to
reduce the number of inspections conducted to meet FDA and other
countries' requirements and to control the scheduling of the inspection
by an accredited organization. For example, the one inspection of a
domestic establishment that an accredited organization completed
independently before October 31, 2006, was a single inspection designed
to meet the requirements of FDA, the European Union, and Canada.
Potential disincentives to participation include bearing the cost for
the inspection and uncertainty about the potential consequences of
making a commitment to having an inspection to assess compliance with
FDA requirements in the near future. Some manufacturers might be
deferring participation in the program. For example, manufacturers that
already contract with a specific accredited organization to conduct
inspections to meet the requirements of other countries might defer
participation until FDA has cleared that organization to conduct
independent inspections. Manufacturers may also participate in the
accredited persons inspection program by hosting training inspections,
and their interest in doing so might be influenced by other factors.
For example, some representatives of affected entities speculated that
some manufacturers may choose not to host training inspections because
of a concern that they might require more time and effort for
manufacturers' staff (and thus be more disruptive) than inspections
conducted by fully trained personnel.
The Department of Health and Human Services provided technical comments
on a draft of this report, which we incorporated as appropriate.
Background:
FDA conducts quality system inspections of medical device
manufacturers' establishments to assess compliance with applicable FDA
regulations, including the quality system regulation to ensure good
manufacturing practices[Footnote 14] and the regulation requiring
reporting of adverse events. FDA's routine postmarket quality system
inspections include both comprehensive and abbreviated inspections,
which differ in the scope of inspectional activity. A comprehensive
postmarket inspection of an establishment assesses multiple aspects of
the manufacturer's quality system, including management activities to
establish, implement, and review the quality system; procedures to
control the design and the production or processing of the device to
ensure that it conforms to specifications and user requirements; and
procedures for preventing, identifying, and correcting quality
problems. Based upon its findings during inspection, FDA classifies
completed inspections into one of three categories based on the extent
to which the establishment deviates from applicable requirements of the
quality system regulation: No action indicated (which indicates no
deviations or only minor deviations), voluntary action indicated (which
indicates minor to significant deviations), or official action
indicated (which indicates significant deviations and warnings).
MDUFMA required FDA to accredit third persons--which are organizations-
-to conduct inspections of certain establishments. Manufacturers that
meet eligibility requirements may request a postmarket inspection by an
FDA-accredited organization.[Footnote 15]
To be eligible to request an inspection of an establishment by an
accredited organization, a manufacturer must:
* manufacture a class II or class III medical device;
* market at least one of those devices in the United States;
* market or intend to market at least one of those devices in a foreign
country and either (a) one of those countries certifies, accredits, or
otherwise recognizes the FDA-accredited organization as authorized to
conduct inspections of establishments or (b) the manufacturer submits a
statement to FDA that the law of one of the countries recognizes an
inspection by FDA or the FDA-accredited organization;[Footnote 16]
* have received, after its most recent inspection, a classification by
FDA as "no action indicated" or "voluntary action indicated" for the
establishment that it seeks to have inspected by an accredited
organization;[Footnote 17] and:
* request and receive FDA's approval to use a specific accredited
organization.
In addition, to be eligible to request an inspection by an accredited
organization, domestic establishments may not have been inspected by
the accredited organization during the previous four years, unless the
manufacturer requests and receives a waiver from FDA, and foreign
establishments must be periodically inspected by FDA.[Footnote 18]
Organizations seeking accreditation to conduct inspections through the
accredited persons inspection program submit applications to FDA for
review. FDA established criteria for accreditation that incorporate the
minimum requirements set out in MDUFMA, including the independence and
competence of the accredited organizations. For example, to ensure the
independence of organizations accredited to conduct inspections of
medical device establishments, MDUFMA prohibits accredited
organizations from engaging in the design, manufacture, promotion, or
sale of articles regulated by FDA, and FDA's criteria include whether
the organization has procedures in place to prevent conflicts of
interest. To ensure that accredited organizations are competent to
conduct inspections, MDUFMA requires that accredited organizations
agree to limit their work to that for which they have sufficient
competence and capacity, and FDA's criteria include whether the
organizations' personnel have knowledge of pertinent FDA laws,
regulations, and inspection procedures. FDA developed a scoring
procedure to evaluate applications from organizations in light of these
and other criteria.
FDA also developed a training program for inspectors from accredited
organizations that involves both formal classroom training and training
inspections of establishments. The formal classroom training includes
instruction on FDA's regulations pertaining to medical devices and
FDA's techniques for conducting quality system inspections. FDA also
requires inspectors to successfully complete three joint inspections
with FDA before being cleared to conduct independent inspections. FDA
relies on manufacturers to volunteer to host these joint inspections.
During the first training inspection, an FDA inspector leads the
inspection and the accredited organization's inspector acts primarily
as an observer. During the second training inspection, the accredited
organization's inspector conducts an inspection while being observed
and evaluated by an FDA inspector who may provide assistance to the
trainee. During the third training inspection, the accredited
organization's inspector conducts an inspection while being observed
and evaluated by an FDA inspector who may not provide assistance to the
trainee. Each individual inspector from an accredited organization must
complete all training requirements successfully before being cleared to
conduct independent inspections.
Manufacturers that want to have an inspection through the accredited
persons inspection program submit a request to FDA that identifies the
accredited organization they intend to use and asks for FDA's approval.
Manufacturers include with that request documentation showing that they
meet the eligibility criteria. FDA can then provide clearance and
approve the request, ask for additional information, or deny the
request. If the request is approved, the manufacturer 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. FDA makes the final
assessment of compliance with applicable requirements.
FDA Accredited 17 of 23 Organizations and Denied Accreditation When
Criteria Were Not Met or Because MDUFMA Limited the Number That Could
Be Accredited:
FDA granted accreditation to 17 of 23 organizations. FDA denied
accreditation to applicants that did not meet minimum criteria because
their applications were not correctly completed or did not demonstrate
technical competence. In addition, some applicants were denied
accreditation because MDUFMA limited the number of organizations that
could be accredited to 15 during the first year after FDA issued
criteria for accreditation.
FDA granted accreditation to 17 of 23 organizations that applied to
conduct inspections of establishments through the accredited persons
inspection program. One or more foreign governments had already
authorized each of these accredited organizations to conduct
inspections to assess compliance with quality system requirements. FDA
announced accreditation of 15 of 22 applicant organizations on November
6, 2003. One of these accredited organizations withdrew from the
program in December 2003, leaving 14 accredited organizations. After
the initial accreditation year, FDA received two additional
applications for accreditation, including one from an organization that
had been denied accreditation during the first year; FDA accredited
both of these organizations. The total number of accredited
organizations as of October 31, 2006, was thus 16.
FDA denied accreditation to applicants that did not meet minimum
criteria because their applications were not correctly completed or did
not demonstrate the applicants' technical competence and because more
organizations met the minimum criteria for accreditation than FDA could
legally accredit. During the first accreditation year, FDA received a
total of 23 applications from 22 organizations. Of these 23
applications, 2 were not correctly completed and the applicants were
denied accreditation. For example, these applications did not include
required documentation showing the authority, responsibility, and
reporting structure of the individuals who would perform work through
the accredited persons inspection program. One of the organizations
that had initially submitted an application that was not correctly
completed submitted a second, correctly completed application within
the first accreditation year. (This second application is included
among the total of 23 applications FDA received during the first
accreditation year.) Thus, FDA received 21 correctly completed
applications from 21 organizations during the first accreditation year.
FDA also denied accreditation to applicants that did not meet minimum
criteria because their applications did not demonstrate that the
applicants had adequate technical competence. To evaluate
organizations' qualifications, FDA developed a checklist for scoring
applications against the criteria for accreditation. A group of FDA
staff assessed the applications and assigned scores to specific
elements, such as technical competence and prevention of conflict of
interest. FDA determined that 2 of the 21 correctly completed
applications did not demonstrate that the organization had adequate
technical competence, and it denied accreditation to these 2
organizations.
FDA found that the remaining 19 organizations that applied for
accreditation during the first accreditation year met the minimum
criteria for accreditation, but it was limited to accrediting 15
organizations during that year. FDA rank-ordered the applications by
the total score it assigned through use of the checklist. FDA granted
accreditation to the 15 organizations with the highest ranking
applications, and denied accreditation to the remaining 4 organizations
with lower-ranking applications.
Two Inspections Independently Conducted by an Accredited Organization:
Between March 11, 2004--the date when FDA first cleared an accredited
organization to conduct independent inspections of establishments--and
October 31, 2006, two accredited organizations conducted independent
inspections--one inspection of a domestic establishment and one
inspection of a foreign establishment. During the same time period, 36
inspections of domestic establishments and 1 inspection of a foreign
establishment were conducted by accredited organizations jointly with
FDA officials as part of the training FDA required of accredited
organizations. As shown in table 1, individuals from 7 of 16 accredited
organizations completed all training requirements and were cleared to
conduct independent inspections by October 17, 2006. The remaining 9
accredited organizations had not completed all training requirements as
of October 31, 2006.
Table 1: Dates on Which FDA Cleared Accredited Organizations to Conduct
Independent Inspections:
Accredited organization: # 1;
Date: March 11, 2004.
Accredited organization: # 2;
Date: May 17, 2004.
Accredited organization: # 3;
Date: June 1, 2004.
Accredited organization: # 4;
Date: July 28, 2004.
Accredited organization: # 5;
Date: April 27, 2005.
Accredited organization: # 6;
Date: September 26, 2006.
Accredited organization: # 7;
Date: October 17, 2006.
Accredited organization: # 8 through # 16;
Date: Pending completion of training requirements as of October 31,
2006.
Source: FDA.
[End of table]
To gain perspective on the number of inspections conducted by
accredited organizations, we asked FDA how many inspections it had
conducted from March 11, 2004, through October 31, 2006, that could
potentially have been conducted by accredited organizations. FDA could
not provide exact counts of these inspections for two reasons. First,
only those manufacturers that market, or intend to market, a device in
a foreign country are eligible to be inspected by an accredited
organization, but FDA does not routinely obtain information about
foreign marketing activities or plans. Second, eligibility for an
inspection by an accredited organization is limited to manufacturers of
class II or III medical devices, but FDA does not have readily
available information about the classification of devices that were
manufactured at establishments at the time of inspection.[Footnote 19]
Instead of providing exact counts of the number of inspections FDA had
conducted that could potentially have been conducted by accredited
organizations, FDA told us how many comprehensive postmarket quality
system inspections it had conducted of establishments where class II or
III medical devices were manufactured as of October 31, 2006, and that
met the criteria for an inspection by an accredited organization other
than the criterion that the manufacturer markets, or intends to market,
a medical device in a foreign country. These counts provide an upper
bound estimate of the number of inspections FDA had conducted that
could potentially have been conducted by accredited organizations. From
March 11, 2004, through October 31, 2006, FDA conducted 229 inspections
of domestic establishments and 48 inspections of foreign
establishments.[Footnote 20]
Several Factors Could Influence Manufacturers' Interest in
Participating in the Program:
According to FDA and representatives of affected entities, several
factors could influence manufacturers' interest in voluntarily
participating in the accredited persons inspection program, whether by
requesting an inspection or by hosting a training inspection. FDA and
representatives of affected entities described factors that could serve
as potential incentives, disincentives, or reasons to defer making a
request for an inspection by an accredited organization. Additional
factors may influence manufacturers' interest in participating in the
program by hosting required training inspections.
Potential incentives to having an inspection by an accredited
organization include the opportunity to reduce the number of
inspections conducted to meet FDA and other countries' requirements and
to control the scheduling of the inspection by an accredited
organization.
* FDA and representatives of affected entities told us that
manufacturers would prefer to reduce the number of inspections they
need to undergo by having a single inspection cover requirements of FDA
and other governments, rather than having separate
inspections.[Footnote 21] One reason for this preference is that
inspections are disruptive to manufacturers. FDA and representatives of
affected entities told us that FDA's requirements are similar, but not
identical, to the requirements of other countries.[Footnote 22] As a
result, a single inspection designed to cover multiple requirements
would likely take more time than a single inspection designed to meet
any one set of requirements, but less time than separate inspections.
Representatives of the accredited organizations with whom we spoke
stated that they expect to be able to address multiple inspection
requirements in a single inspection, and the one inspection of a
domestic establishment that an accredited organization completed
independently before October 31, 2006, was a single inspection designed
to meet the requirements of FDA, the European Union, and Canada.
* According to FDA and many representatives of affected entities,
another potential incentive to requesting an inspection by an
accredited organization is that manufacturers can work with accredited
organizations to schedule inspections and can schedule them months in
advance. In contrast, FDA generally notifies manufacturers of
inspections about a week in advance. The reasons representatives of
affected entities gave for the preference for scheduling inspections
well in advance include that it enables them to ensure the availability
of their quality managers and minimize disruption to their normal work
activities.
FDA and representatives of affected entities told us that the potential
disincentives to having an inspection by an accredited organization
include bearing the cost for the inspection, doubts about whether
accredited organizations can cover multiple requirements in a single
inspection, and uncertainty about the potential consequences of making
a commitment to having an inspection to assess compliance with FDA
requirements in the near future.
* Manufacturers pay for inspections that are conducted by accredited
organizations; in contrast, manufacturers are not charged for
inspections conducted by FDA.[Footnote 23] Manufacturers that already
pay for inspections to meet requirements of foreign countries will
likely face a higher cost for an inspection that also covers FDA
requirements because the requirements are not identical and the
inspection will therefore likely take longer. FDA and representatives
of affected entities stated that bearing the cost for the inspection
might be a disincentive to participation in the program, and some of
these representatives suggested that cost could be particularly
important to small manufacturers.
* Although a goal of the accredited persons inspection program is to
reduce the total number of inspections for manufacturers that market
devices in the United States and other countries, some representatives
of FDA and manufacturers raised doubts about whether the accredited
organizations could cover multiple requirements in a single inspection.
One of them told us that the accredited organization that inspects its
establishments stated that it would not combine the inspection to
assess compliance with FDA requirements with an inspection to address
other requirements, and would instead conduct two separate inspections.
Similarly, some FDA officials expressed uncertainty about whether all
of the accredited organizations would develop inspection strategies
that effectively address multiple requirements. FDA and Canada are in
the process of establishing a pilot program to assess whether
accredited organizations can meet the requirements of both countries in
a single inspection.
* In addition, uncertainty about the potential consequences of making a
commitment to having an inspection to assess compliance with FDA
requirements in the near future is a potential disincentive.
Manufacturers who request an inspection by an accredited organization
are committing to an inspection to assess compliance with FDA
requirements in the near future, even though it is possible that FDA
would not inspect them in the next 5 or 6 years--and inspections carry
the risk of regulatory action. FDA and most of the representatives of
affected entities with whom we spoke told us that this commitment to an
inspection is a potential disincentive to participation in the program.
For example, one industry representative questioned why manufacturers
would ask for--and pay for--inspections when the result could be that
FDA closes them down. In addition, because FDA will make the final
determination of compliance with its requirements, some representatives
of affected entities suggested that manufacturers might be uncertain
about whether the accredited organization's inspection will satisfy
FDA, or whether FDA will conduct an additional inspection after reading
the report prepared by the accredited organization.
Some representatives of affected entities suggested that manufacturers
might defer a decision about whether to request an inspection by an
accredited organization until uncertainties about the potential
incentives and disincentives have been reduced. For example,
manufacturers might defer a decision until there is greater certainty
about whether accredited organizations are able to conduct single
inspections to cover multiple sets of requirements and about how FDA
will respond to the inspection reports prepared by accredited
organizations.
According to representatives of affected entities, some manufacturers-
-those that are already paying to have routine quality system
inspections of their establishments to meet the requirements of other
countries--might have other reasons for deferring a request for an
inspection by an accredited organization. Manufacturers that already
contract with a specific accredited organization to conduct inspections
to meet the requirements of other countries might defer participation
until that organization has completed all required training and been
cleared by FDA to conduct independent inspections. In addition, because
manufacturers want to minimize the disruptiveness of inspections, they
might defer requesting an inspection through FDA's accredited persons
inspection program until accredited organizations have honed their
procedures for conducting inspections to cover FDA's requirements.
Manufacturers' participation in the accredited persons inspection
program also includes their willingness to host training inspections.
In addition to some of the potential incentives and disincentives to
requesting an inspection by an accredited organization, other factors
may have influenced manufacturers' interest in hosting required
training inspections. Fewer manufacturers have volunteered to host
training inspections than needed for all of the accredited
organizations to complete their training. Some representatives of
affected entities speculated that manufacturers might have 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. Moreover, FDA and
representatives of affected entities indicated that scheduling training
inspections was difficult. For example, FDA schedules inspections a
relatively short period of time prior to the actual inspection, and
some accredited organizations were not available to participate because
they had already made prior commitments.
Agency Comments:
We provided a draft of this report to the Department of Health and
Human Services for comment. The department stated that our report
provides an accurate and balanced explanation of the accredited persons
inspection program and provided technical comments, which we
incorporated as appropriate.
We are sending copies of this report to the Secretary of Health and
Human Services and the Commissioner of FDA, appropriate congressional
committees, and other interested parties. We will also make copies
available to others on request. In addition, the report is available at
no charge on the GAO Web site at [Hyperlink, http://www.gao.gov]. If
you or your staffs have questions about this report, please contact me
at (202) 512-7119 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 III.
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Inspections Conducted by the Food and Drug Administration:
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
requires us to report on the number of inspections of medical device
establishments conducted by the Food and Drug Administration
(FDA).[Footnote 24] We are reporting the number of postmarket quality
system inspections of domestic establishments where medium or high risk
medical devices (referred to as class II or class III medical devices)
are manufactured[Footnote 25] and the number of inspections of foreign
medical device establishments conducted by FDA.
To provide this information, we asked FDA how many inspections it
conducted from March 11, 2004--the date when FDA first cleared an
accredited organization to conduct independent inspections--through
October 31, 2006. With regard to domestic establishments, we asked for
the number of quality system inspections of establishments where class
II or class III medical devices are manufactured. FDA provided us with
the number of such inspections based on the classification of medical
devices as of October 31, 2006, because FDA does not have readily
available information about the classification of devices manufactured
at the establishments at the time of inspection. FDA updates the
information about device classification in its inspection database when
the types of medical devices an establishment handles changes, for
example, when a manufacturer changes its device inventory or when FDA
reclassifies a device.[Footnote 26] Based on our review of FDA
documents and discussions with FDA officials, we determined that the
data FDA provided were sufficiently reliable for the purposes of this
report.
FDA reported that from March 11, 2004, through October 31, 2006, it
conducted 2,814 postmarket quality system inspections of domestic
establishments where a class II or III medical device was manufactured
as of October 31, 2006. These establishments included medical device
manufacturers and remanufacturers, packers and repackers, labelers and
relabelers, contract sterilizers, software manufacturers, and
reprocessors. During this time period, another 86 domestic inspections
were conducted by state investigators under contract to FDA. FDA also
reported that it conducted 656 inspections of foreign medical device
establishments from March 11, 2004, through October 31, 2006.[Footnote
27]
[End of section]
Appendix II: Scope and Methodology:
To determine the number of organizations that sought accreditation, the
number that were accredited, and reasons for denial of accreditation,
we reviewed FDA documentation of the number of applications for
accreditation it received and its evaluation of those applications, and
we interviewed FDA officials.
To determine the number of inspections of foreign and domestic
establishments conducted by accredited persons, we asked FDA to provide
counts of the number of inspections conducted from March 11, 2004--the
date when FDA first cleared an accredited organization to conduct
independent inspections--through October 31, 2006. Based on our review
of FDA documents and discussions with FDA officials, we determined that
the data were sufficiently reliable for our purposes.
To determine whether there are factors that could influence
manufacturers' interest in voluntarily participating in FDA's
accredited persons inspection program, we interviewed FDA officials and
representatives of affected entities. As indicated in table 2, the
affected entities with which we conducted interviews were four
accredited organizations, three organizations that represent medical
device manufacturers, and six global medical device manufacturers. For
our sample of accredited organizations, we selected two that had been
cleared by FDA to conduct independent inspections as of April 2006 and
two that had not. To select our sample of manufacturers, we asked the
representatives of each of the three organizations that represent
manufacturers to provide us with a list of five manufacturers. Two of
the organizations provided lists of five manufactures and one
organization provided a list of four manufacturers. We randomly
selected two global manufacturers from each list. The information we
obtained from these representatives of affected entities can not be
generalized to other manufacturers or accredited organizations.
Table 2: Affected Entities with Which We Conducted Interviews:
Type of affected entity: Organizations that FDA accredited to conduct
inspections;
Specific entity:
* Danish Standards;
* KEMA Quality B.V;
* TUV Rheinland of North America, Inc;
* Underwriters Laboratories, Inc..
Type of affected entity: Organizations that represent medical device
manufacturers;
Specific entity:
* Advanced Medical Technology Association (AdvaMed);
* Medical Device Manufacturers Association (MDMA);
* National Electrical Manufacturers Association (NEMA).
Type of affected entity: Global manufacturers of medical devices;
Specific entity:
* Abbott Laboratories;
* Acorn Cardiovascular, Inc;
* Gen-Probe, Inc;
* Philips Medical Systems;
* Siemens Medical Solutions;
* Wescor, Inc..
Source: GAO.
[End of table]
We also reviewed applicable law, regulations, legislative history, FDA
guidance, and other relevant documents. We conducted our work from
February 2006 through November 2006 in accordance with generally
accepted government auditing standards.
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7119 or crossem@gao.gov:
Acknowledgments:
In addition to the contact named above, James McClyde, Assistant
Director; Kristen Joan Anderson; Cathleen J. Hamann; and Julian Klazkin
made key contributions to this report.
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) (2006). Medical device manufacturers may have more than one
establishment.
[3] We use the term "manufacture" to refer to activities including
manufacturing, preparing, and processing devices.
[4] 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. 21 C.F.R. §§ 820.1, 820.3(v), 820.20.
[5] 21 U.S.C. § 360(h). Although there is no similar requirement for
FDA's inspections of foreign medical device establishments, the
products manufactured at such establishments may be prohibited from
importation into the United States if an FDA request to inspect is
denied. 21 U.S.C. § 381(a), 21 C.F.R. § 820.1(d) (2006).
[6] 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.
[7] H.R. Rep. No. 107-728, at 32-36 (2002).
[8] See Pub. L. No. 107-250, § 201, 116 Stat. 1588, 1602-1609
(codified, as amended, at 21 U.S.C. § 374(g)).
[9] Pub. L. No. 108-214, § 2(b)(1), 118 Stat. 572-575.
[10] FDA conducts both premarket and postmarket inspections of
establishments. Premarket inspections are conducted prior to the
initial introduction of devices into the U.S. market. Postmarket
inspections occur after a device has already been marketed.
[11] FDA officials told us that they can not tell how many
manufacturers meet the criteria for participation in the accredited
persons inspection program because it does not routinely collect
information about whether manufacturers market, or intend to market,
medical devices in foreign countries.
[12] FDA issued criteria for accreditation on April 28, 2003. 68 Fed.
Reg. 22400. MDUFMA did not limit the number of organizations that FDA
could accredit after the 1st accreditation year.
[13] 21 U.S.C. § 374(g)(12).
[14] See 21 C.F.R. pt. 820 (2006).
[15] 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 (that is, inspections conducted in response to
specific information that raised questions, concerns, or problems such
as a potential serious health risk). FDA may conduct its own
inspections of establishments even after inspection by an accredited
organization.
[16] FDA officials told us that they are not aware of any country where
the law recognizes an inspection by FDA, and that only organizations
that are certified, accredited, or otherwise recognized by one or more
foreign countries to conduct inspections of establishments can conduct
inspections through FDA's accredited persons inspection program.
[17] If a manufacturer's most recent inspection was conducted by an
accredited organization and FDA classified it as official action
indicated, but the manufacturer meets all other eligibility criteria
for the accredited persons inspection program, the manufacturer may
petition FDA for an exception. The petition should explain how the
manufacturer corrected the identified problems.
[18] As enacted, MDUFMA prohibited an inspection of an establishment by
an accredited organization if its two immediately preceding inspections
had been conducted by an accredited organization, unless the
manufacturer requested and received approval from FDA. Because
accredited organizations often completed inspections in two or more
visits, this provision, in effect, limited manufacturers to no more
than one completed inspection of an establishment by an accredited
organization. In part, in an attempt to correct this limitation,
Congress passed the Medical Devices Technical Corrections Act, Pub. L.
No. 108-214, § 2(b)(1), 118 Stat. 572, 573-574, which included a
provision excluding establishments inspected by accredited
organizations during the previous four years. According to a report of
the U.S. House Committee on Energy and Commerce accompanying the act,
this provision was intended to ensure "that [establishments] can work
with [accredited organizations] to allow them to complete a full
[quality system] inspection over the course of a two year period . . .
[and] can use [accredited organizations] for two consecutive [quality
system] inspections before requesting special permission from [FDA] for
the third such inspection." H.R. Rep. No 108-433, at 8 (2004). FDA
guidance, which reflects the objectives stated in the committee report,
states: "The change limits the use of [inspections by accredited
organizations] to a four-year period rather than a limit of two
consecutive inspections. This reflects [the Medical Devices Technical
Corrections Act's] shift to permit an inspection by an accredited
[organization] to be completed in stages during a two-year period.
Because a complete [inspection by an accredited organization] must be
completed within two years, FDA expects two complete [inspections by
accredited organizations] during the four-year period provided by this
section." However, instead of expanding the use of accredited
organizations, this provision would appear to disqualify a manufacturer
for four years after any one inspection by an accredited organization,
contrary to the committee report and FDA guidance. An FDA official
acknowledged the problem and stated that it is considering a proposal
for an additional technical correction to address it. No establishment
has been found ineligible for an inspection by an accredited
organization on the basis of this criterion.
[19] When a manufacturer changes its device inventory or when FDA
reclassifies a device, FDA replaces the existing information about
device classification in its inspection database with the new
information. For example, if a class II medical device was manufactured
at an establishment at the time when it was inspected, and the
manufacturer subsequently stopped manufacturing that device and now
manufactures only class I medical devices, then FDA's database would
not indicate that class II devices had been manufactured at the
establishment at the time of inspection. An FDA official told us that
the classification of medical devices handled by specific
establishments is generally relatively stable over time periods of
approximately 2 years.
[20] See app. I for information on the number of postmarket quality
system inspections of domestic establishments where class II or class
III medical devices are manufactured and the number of inspections of
foreign establishments where medical devices are manufactured that FDA
conducted.
[21] 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.
[22] The United States and other countries are working to bring their
requirements for inspections of medical device establishments into line
with one another, that is, to harmonize their requirements. The
majority of representatives of affected entities with whom we spoke
supported harmonization.
[23] Representatives of the accredited organizations with whom we spoke
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.
[24] 21 U.S.C. § 374(g)(12)(A).
[25] We use the term "manufacture" to refer to activities including
manufacturing, preparing, and processing devices.
[26] An FDA official told us that the classification of medical devices
handled by specific establishments is generally relatively stable over
time periods of approximately 2 years.
[27] During this time period, FDA also conducted 36 inspections of
domestic establishments and 1 inspection of a foreign establishment
jointly with accredited organizations as part of the training FDA
required of these organizations.
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