United States Government Accountability Office

GAO Report to Congressional Committees

MEDICAL DEVICES

Status of FDA’s 

Program for 

Inspections by 

Accredited 

Organizations 

January 2007 

 

GAO-07-157 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

January 2007

MEDICAL DEVICES

Status of FDA’s Program for Inspections 

Highlights of GAO-07-157, a report to by Accredited Organizations 

congressional committees 

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. 

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. 

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. 
Contents 

Letter 1

Results in Brief 4

Background 6

FDA Accredited 17 of 23 Organizations and Denied Accreditation 

When Criteria Were Not Met or Because MDUFMA Limited the 

Number That Could Be Accredited 10 

Two Inspections Independently Conducted by an Accredited 

Organization 11

Several Factors Could Influence Manufacturers’ Interest in 

Participating in the Program 13 

Agency Comments 17 

Appendix I Inspections Conducted by the Food and Drug 

Administration 18 

Appendix II Scope and Methodology 20 

Appendix III GAO Contact and Staff Acknowledgments 22 

Tables 

Table 1: Dates on Which FDA Cleared Accredited Organizations to 

Conduct Independent Inspections 12 

Table 2: Affected Entities with Which We Conducted Interviews 21 

Page i GAO-07-157 Inspections by Accredited Organizations
Abbreviations 

FDA Food and Drug Administration 

GMP good manufacturing practices

MDUFMA Medical Device User Fee and Modernization Act of 2002 

This is a work of the U.S. government and is not subject to copyright protection in the 

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reproduce this material separately. 

Page ii GAO-07-157 Inspections by Accredited Organizations
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.1

 As part of its 

responsibilities, FDA inspects domestic and foreign establishments2

 where 

medical devices that are marketed in the United States are manufactured3

to assess compliance with FDA’s quality system requirements4

 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 

 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. 

Page 1 GAO-07-157 Inspections by Accredited Organizations
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.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.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.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 

 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). 

Page 2 GAO-07-157 Inspections by Accredited Organizations
foreign countries meet multiple inspection requirements with fewer 

inspections.8

Specifically, MDUFMA, as amended by the Medical Devices Technical 

Corrections Act,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.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.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 15.12

 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. 

10FDA 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. 

11FDA 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. 

12FDA 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. 

Page 3 GAO-07-157 Inspections by Accredited Organizations
MDUFMA requires us to report on several aspects of FDA’s accredited 

persons inspection program.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. 

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 

Results in Brief 

 1321 U.S.C. § 374(g)(12). 

Page 4 GAO-07-157 Inspections by Accredited Organizations
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

Page 5 GAO-07-157 Inspections by Accredited Organizations
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.

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 practices14 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). 

Background 

MDUFMA required FDA to accredit third persons—which are 

organizations—to conduct inspections of certain establishments. 

 14See 21 C.F.R. pt. 820 (2006). 

Page 6 GAO-07-157 Inspections by Accredited Organizations
Manufacturers that meet eligibility requirements may request a postmarket 

inspection by an FDA-accredited organization.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;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;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 

 15Accredited 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. 

16FDA 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.

17If 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.

Page 7 GAO-07-157 Inspections by Accredited Organizations
manufacturer requests and receives a waiver from FDA, and foreign 

establishments must be periodically inspected by FDA.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. 

 18As 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. 

Page 8 GAO-07-157 Inspections by Accredited Organizations
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. 

Page 9 GAO-07-157 Inspections by Accredited Organizations
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 

FDA Accredited 17 of 

23 Organizations and 

Denied Accreditation 

When Criteria Were 

Not Met or Because 

MDUFMA Limited the 

Number That Could 

Be Accredited 

Page 10 GAO-07-157 Inspections by Accredited Organizations
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. 

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. 

Two Inspections 

Independently 

Conducted by an 

Accredited 

Organization 

Page 11 GAO-07-157 Inspections by Accredited Organizations
Table 1: Dates on Which FDA Cleared Accredited Organizations to Conduct 

Independent Inspections

Accredited organization Date 

# 1 March 11, 2004

# 2 May 17, 2004 

# 3 June 1, 2004 

# 4 July 28, 2004 

# 5 April 27, 2005 

# 6 September 26, 2006 

# 7 October 17, 2006 

# 8 through # 16 Pending completion of training 

requirements as of October 31, 2006 

Source: FDA. 

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.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 

 19When 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.

Page 12 GAO-07-157 Inspections by Accredited Organizations
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.20

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.

Several Factors Could 

Influence 

Manufacturers’ 

Interest in 

Participating in the 

Program 

• 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.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 

 20See 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. 

21We 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. 

Page 13 GAO-07-157 Inspections by Accredited Organizations
are similar, but not identical, to the requirements of other countries.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. 

 22The 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. 

Page 14 GAO-07-157 Inspections by Accredited Organizations
• Manufacturers pay for inspections that are conducted by accredited 

organizations; in contrast, manufacturers are not charged for inspections 

conducted by FDA.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

 23Representatives 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. 

Page 15 GAO-07-157 Inspections by Accredited Organizations
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 

Page 16 GAO-07-157 Inspections by Accredited Organizations
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. 

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 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. 

Marcia Crosse 

Director, Health Care 

Agency Comments 

Page 17 GAO-07-157 Inspections by Accredited Organizations
Appendix I: Inspections Conducted by the Appendix I: Inspections Conducted by the Food and Drug Administration 

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).1

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 manufactured2

 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.

3

 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 

 1

21 U.S.C. § 374(g)(12)(A).

2

We use the term “manufacture” to refer to activities including manufacturing, preparing, 

and processing devices.

3

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. 

Page 18 GAO-07-157 Inspections by Accredited Organizations
Appendix I: Inspections Conducted by the 

Food and Drug Administration 

conducted 656 inspections of foreign medical device establishments from

March 11, 2004, through October 31, 2006.

4

 4

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. 

Page 19 GAO-07-157 Inspections by Accredited Organizations
Appendix II: Scope and Methodology 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. 

Page 20 GAO-07-157 Inspections by Accredited Organizations
Appendix II: Scope and Methodology 

Table 2: Affected Entities with Which We Conducted Interviews 

Type of affected entity Specific entity 

Organizations that FDA accredited to 

conduct inspections 

• Danish Standards 

• KEMA Quality B.V. 

• TUV Rheinland of North America, Inc. 

• Underwriters Laboratories, Inc. 

Organizations that represent medical

device manufacturers 

• Advanced Medical Technology 

Association (AdvaMed) 

• Medical Device Manufacturers

Association (MDMA) 

• National Electrical Manufacturers 

Association (NEMA) 

Global manufacturers of medical devices • Abbott Laboratories 

• Acorn Cardiovascular, Inc. 

• Gen-Probe, Inc. 

• Philips Medical Systems 

• Siemens Medical Solutions 

• Wescor, Inc. 

Source: GAO.

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. 

Page 21 GAO-07-157 Inspections by Accredited Organizations
Appendix III: GAO

A

 Contact and Staff 

cknowledgments 

Page 22 GAO-07-157

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact Marcia Crosse, (202) 512-7119 or crossem@gao.gov 

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. 

Inspections by Accredited Organizations

Acknowledgments 

(290508) 
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