Medical Devices: Challenges for FDA in Conducting Manufacturer	 
Inspections (29-JAN-08, GAO-08-428T).				 
                                                                 
As part of the Food and Drug Administration's (FDA) oversight of 
the safety and effectiveness of medical devices marketed in the  
United States, it inspects domestic and foreign establishments	 
where these devices are manufactured. To help FDA address	 
shortcomings in its inspection program, the Medical Device User  
Fee and Modernization Act of 2002 required FDA to accredit third 
parties to inspect certain establishments. In response, FDA has  
implemented two such voluntary programs. GAO previously reported 
on the status of one of these programs, citing concerns regarding
its implementation and factors that may influence manufacturers' 
participation. (Medical Devices: Status of FDA's Program for	 
Inspections by Accredited Organizations, GAO-07-157, January	 
2007.) This statement (1) assesses FDA's management of		 
inspections of establishments--particularly those in foreign	 
countries--manufacturing devices for the U.S. market, and (2)	 
provides the status of FDA's programs for third-party inspections
of medical device manufacturing establishments. GAO interviewed  
FDA officials; reviewed pertinent statutes, regulations,	 
guidance, and reports; and analyzed information from FDA	 
databases. GAO also updated its previous work on FDA's programs  
for inspections by accredited third parties.			 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-428T					        
    ACCNO:   A80232						        
  TITLE:     Medical Devices: Challenges for FDA in Conducting	      
Manufacturer Inspections					 
     DATE:   01/29/2008 
  SUBJECT:   Certification and accreditation			 
	     Eligibility determinations 			 
	     Evaluation criteria				 
	     Inspection 					 
	     Institution accreditation				 
	     Manufacturing industry				 
	     Medical equipment					 
	     Program evaluation 				 
	     Quality control					 
	     Schedule slippages 				 
	     Voluntary compliance				 
	     FDA Inspection By Accredited Persons		 
	     Program						 
                                                                 

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GAO-08-428T

   

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United States Government Accountability Office: 
GAO: 

Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

For Release on Delivery: 
Expected at 10:00 a.m. EST: 
Tuesday, January 29, 2008: 

Medical Devices: 

Challenges for FDA in Conducting Manufacturer Inspections: 

Statement of Marcia Crosse 
Director, Health Care: 

GAO-08-428T: 

GAO Highlights: 

Highlights of GAO-08-428T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

Why GAO Did This Study: 

As part of the Food and Drug Administrationï¿½s (FDA) oversight of the 
safety and effectiveness of medical devices marketed in the United 
States, it inspects domestic and foreign establishments where these 
devices are manufactured. To help FDA address shortcomings in its 
inspection program, the Medical Device User Fee and Modernization Act 
of 2002 required FDA to accredit third parties to inspect certain 
establishments. In response, FDA has implemented two such voluntary 
programs. GAO previously reported on the status of one of these 
programs, citing concerns regarding its implementation and factors that 
may influence manufacturersï¿½ participation. (Medical Devices: Status of 
FDAï¿½s Program for Inspections by Accredited Organizations, GAO-07-157, 
January 2007.) 

This statement (1) assesses FDAï¿½s management of inspections of 
establishmentsï¿½particularly those in foreign countriesï¿½manufacturing 
devices for the U.S. market, and (2) provides the status of FDAï¿½s 
programs for third-party inspections of medical device manufacturing 
establishments. GAO interviewed FDA officials; reviewed pertinent 
statutes, regulations, guidance, and reports; and analyzed information 
from FDA databases. GAO also updated its previous work on FDAï¿½s 
programs for inspections by accredited third parties. 

What GAO Found: 

FDA has not met the statutory requirement to inspect certain domestic 
establishments manufacturing medical devices every 2 years, and the 
agency faces challenges inspecting foreign establishments. FDA 
primarily inspected establishments located in the United States. The 
agency has not met the biennial inspection requirement for domestic 
establishments manufacturing medical devices that FDA has classified as 
high risk, such as pacemakers, or medium risk, such as hearing aids. 
FDA officials estimated that the agency has inspected these 
establishments every 3 years (for high risk devices) or 5 years (for 
medium risk devices). There is no comparable requirement to inspect 
foreign establishments, and agency officials estimate that these 
establishments have been inspected every 6 years (for high risk 
devices) or 27 years (for medium risk devices). FDA faces challenges in 
managing its inspections of foreign medical device establishments. Two 
databases that provide FDA with information about foreign medical 
device establishments and the products they manufacture for the U.S. 
market contain inaccuracies that create disparate estimates of 
establishments subject to FDA inspection. Although comparing 
information from these two databases could help FDA determine the 
number of foreign establishments marketing medical devices in the 
United States, these databases cannot exchange information and any 
comparisons must be done manually. Finally, inspections of foreign 
medical device manufacturing establishments pose unique challenges to 
FDA in human resources and logistics. 

Few inspections of medical device manufacturing establishments have 
been conducted through FDAï¿½s two accredited third-party inspection 
programsï¿½the Accredited Persons Inspection Program and the Pilot Multi-
purpose Audit Program (PMAP). From March 11, 2004ï¿½the date when FDA 
first cleared an accredited organization to conduct independent 
inspectionsï¿½through January 11, 2008, five inspections have been 
conducted by accredited organizations through FDAï¿½s Accredited Persons 
Inspection Program. An incentive to participation in the program is the 
opportunity to reduce the number of inspections conducted to meet FDA 
and other countriesï¿½ requirements. Disincentives include bearing the 
cost for the inspection, particularly when the consequences of an 
inspection that otherwise might not occur in the near future could 
involve regulatory action. The Food and Drug Administration Amendments 
Act of 2007 made several changes to program eligibility requirements 
that could result in increased participation by manufacturers. PMAP was 
established on September 7, 2006, and as of January 11, 2008, two 
inspections had been conducted by an accredited organization through 
this program, which is more limited than the Accredited Persons 
Inspection Program. The small number of inspections completed to date 
by accredited third-party organizations raises questions about the 
practicality and effectiveness of establishing similar programs that 
rely on third parties to quickly help FDA fulfill its responsibilities. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.GAO-08-428T]. For more information, contact 
Marcia Crosse at (202) 512-7114 or [email protected]. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today as you examine how the Food and Drug 
Administration (FDA) has been meeting its regulatory responsibilities. 
One area of FDA responsibility is the regulation of medical 
devices[Footnote 1]--such as hearing aids and pacemakers--marketed in 
the United States, whether manufactured in domestic or foreign 
establishments.[Footnote 2] FDA classifies medical devices into one of 
three classes based on degree of potential risk and level of control 
needed to reasonably ensure safety and effectiveness.[Footnote 3] 
Inspection of establishments is FDA's primary means of assuring that 
the safety and effectiveness of medical devices are not jeopardized by 
poor manufacturing practices. Requirements governing domestic and 
foreign inspections differ. Specifically, FDA is required to inspect 
domestic establishments that manufacture class II (medium risk) or III 
(high risk) medical devices every 2 years.[Footnote 4] There is no 
comparable requirement to inspect foreign establishments. 

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
addressed concerns about FDA's ability to meet its responsibilities for 
inspecting medical device manufacturing establishments.[Footnote 5] 
MDUFMA included provisions designed to (1) increase the number of 
inspected medical device manufacturing establishments and (2) help 
manufacturers meet the inspection requirements of both the United 
States and foreign countries in a single inspection. Specifically, 
MDUFMA required FDA to accredit third-party organizations to conduct 
inspections of certain domestic and foreign establishments.[Footnote 6] 
In response, FDA implemented its Accredited Persons Inspection Program, 
which permits certain establishments to voluntarily request inspections 
from third-party organizations to meet inspectional requirements. In 
January 2007, we reported on the status of this program citing, among 
other things, concerns regarding its implementation and potential 
incentives and disincentives that may influence manufacturers' 
participation.[Footnote 7] Additionally, in partnership with Health 
Canada,[Footnote 8] FDA has established another program for inspection 
by accredited third parties--the Pilot Multi-purpose Audit Program 
(PMAP)--that allows accredited organizations to conduct a single 
inspection to meet the regulatory requirements of both countries. A 
report by the House of Representatives Committee on Energy and Commerce 
that accompanied MDUFMA stated that inspections by accredited third 
parties would permit FDA to focus the agency's inspection resources on 
manufacturers that have greater problems and devices that present 
higher risks.[Footnote 9] 

In addition to the questions about medical devices that led to the 
creation of FDA's third-party inspection program, questions have also 
been raised about how FDA is meeting its regulatory responsibilities in 
other program areas, such as drugs. In November 2007, we testified on 
our preliminary findings regarding FDA's program for inspecting foreign 
drug manufacturers.[Footnote 10] Our findings suggested that FDA 
conducted infrequent inspections; had weaknesses in its data systems, 
including conflicting information on the number of foreign 
establishments; and faced challenges unique to foreign inspections, 
including those involving human resource issues. (See app. I for a 
summary of that testimony. We plan to issue a final report at a later 
date.) Also in November 2007, a subcommittee of the FDA Science 
Board[Footnote 11] issued a report that identified growing demands on 
FDA, including the globalization of the industries that FDA regulates. 
The report found that disparities between FDA's responsibilities and 
its available resources--including human resources--have resulted in 
serious weaknesses that jeopardize the agency's ability to meet current 
and emerging regulatory responsibilities.[Footnote 12] The 
subcommittee's report noted that these weaknesses include inadequate 
inspections of manufacturers. It also emphasized that FDA's information 
technology infrastructure is obsolete and unstable; provides an 
insufficient basis to access, integrate, and analyze data; and is 
subject to frequent system failures. 

Third-party organizations have been identified as one mechanism that 
could help FDA address shortcomings in inspection programs, beyond the 
programs for medical devices. The federal Interagency Working Group on 
Import Safety recently suggested that the use of third-party 
organizations could provide FDA with information to help the agency 
target its inspection resources to those products of greatest 
risk.[Footnote 13] In addition, we recommended that FDA consider 
developing a third-party inspection program to help it meet its 
responsibilities for inspecting foreign firms importing seafood to the 
United States.[Footnote 14] 

Given the recent questions regarding FDA's inspection programs and 
suggestions that third-party organizations could supplement FDA's 
resources, you asked for information on FDA's management of its medical 
device inspection program. My remarks will focus on (1) our assessment 
of FDA's program for inspecting establishments that manufacture medical 
devices for the U.S. market, particularly those located in foreign 
countries and (2) the status of FDA's programs for third-party 
inspections of medical device manufacturing establishments. Today, in a 
separate statement, we are also discussing the federal oversight of 
food safety as a high-risk area and ways in which FDA can better 
leverage its resources.[Footnote 15] These and other recent testimonies 
on drug safety and food safety offer some observations on FDA's 
inspection program capacity. 

To address these issues, we interviewed officials from FDA's Center for 
Devices and Radiological Health (CDRH) and Office of Regulatory Affairs 
(ORA), which each have responsibilities for managing the medical device 
inspection program.[Footnote 16] We reviewed pertinent statutes and 
regulations, as well as agency documents that provide guidance on FDA's 
inspection requirements and programs for inspections by accredited 
third parties. To assess FDA's program for inspecting establishments 
that manufacture medical devices, we obtained information from FDA's 
Device Registration and Listing System (DRLS), as of September 19, 
2007; Field Accomplishments and Compliance Tracking System (FACTS) for 
fiscal year 2002 through fiscal year 2007; and Operational and 
Administrative System for Import Support (OASIS) for fiscal year 2007. 
We assessed the reliability of these data by (1) reviewing existing 
information about the data and the databases that produced them, (2) 
interviewing agency officials knowledgeable about the data, and (3) 
performing electronic testing of data elements from DRLS and FACTS. We 
found the data in the FACTS database sufficiently reliable for our 
purposes. We also found that DRLS was sufficiently reliable, to the 
extent that it accurately reflects information provided by domestic and 
foreign establishments that register to market medical devices in the 
United States. However, we determined that these data do not 
necessarily reflect the number of establishments that manufacture 
medical devices for the U.S. market. In addition, we found that OASIS 
is likely to overestimate the number of foreign establishments whose 
medical devices have been imported into the United States, due to 
uncorrected errors in the data. Therefore, we present information from 
both DRLS and OASIS to illustrate the variability in information that 
FDA's databases provide to agency officials on this topic. These data 
represent the best information available and are what FDA relies on to 
manage its domestic and foreign medical device inspection activities. 

To examine the status of FDA's programs for third-party inspections, we 
received FDA data on the number of inspections conducted by accredited 
third parties from March 11, 2004--the date when FDA first cleared an 
accredited organization to conduct inspections--through January 11, 
2008. This updates the data we obtained for our January 2007 report for 
which data collection ended on October 31, 2006. We also obtained 
information from FDA about other critical aspects of their programs for 
inspections by accredited third parties, such as the number of 
accredited organizations. To gain perspective on recent changes to 
FDA's programs for inspections by accredited third parties, we 
contacted representatives of the same 13 affected entities we 
interviewed for our January 2007 report on this topic.[Footnote 17] We 
received responses from 2 of 4 accredited organizations, 2 of 3 
organizations that represent medical device manufacturers, and 1 of 6 
manufacturers. We received technical comments on a draft of this 
statement from FDA, which we incorporated, as appropriate. We conducted 
this performance audit from December 2007 to January 2008, in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

In summary, we found that FDA has not met the requirement to inspect 
domestic establishments manufacturing class II or III medical devices 
every 2 years and faces challenges in inspecting foreign 
establishments. FDA primarily inspected domestic establishments. FDA 
officials estimated that the agency has inspected domestic class II 
manufacturers every 5 years and domestic class III manufacturers every 
3 years. There is no comparable requirement to conduct foreign 
inspections and FDA has conducted relatively few. Officials estimated 
the agency has inspected foreign class II manufacturers every 27 years 
and foreign class III manufacturers every 6 years. In addition, FDA 
faces challenges in managing its foreign medical device inspection 
program. Two databases that provide FDA with information about foreign 
medical device establishments and the products they manufacture for the 
U.S. market contain inaccuracies that create divergent estimates of 
establishments subject to FDA inspection. Despite the divergent 
estimates, FDA does not routinely verify these data. Although comparing 
information from these two databases could help FDA determine the 
number of foreign establishments marketing medical devices in the 
United States, these databases cannot exchange information and any 
comparisons must be done manually. While the agency has taken steps to 
improve these databases, it is too soon to know if these changes will 
improve FDA's data. Finally, inspections of foreign medical device 
manufacturing establishments pose unique challenges to FDA, such as 
difficulties in recruiting investigators to voluntarily travel to 
certain countries and in extending trips if problems are identified 
during inspections. Our results are consistent with our November 2007 
testimony on FDA's foreign drug inspection program, as well as the 
findings of the FDA Science Board. 

Few inspections of medical device manufacturing establishments have 
been conducted through FDA's two programs for inspections by accredited 
third parties--the Accredited Persons Inspection Program and PMAP. From 
March 11, 2004--the date when FDA first cleared an accredited 
organization to conduct inspections--through January 11, 2008, five 
inspections have been conducted by accredited organizations through 
FDA's Accredited Persons Inspection Program. Manufacturers' decisions 
to request an inspection by an accredited organization might be 
influenced by both potential incentives and disincentives. An incentive 
to participation in the program is the opportunity to reduce the number 
of inspections conducted to meet FDA and other countries' requirements. 
Disincentives include bearing the cost for the inspection, particularly 
when the consequences of an inspection that otherwise may not occur in 
the near future could involve regulatory action. The Food and Drug 
Administration Amendments Act of 2007 (FDAAA) changed the requirements 
for inspections by accredited third parties in several ways, which 
could result in increased participation by manufacturers, although it 
is too soon to tell. For example, an eligibility requirement that 
foreign establishments be periodically inspected by FDA was eliminated. 
Device manufacturers may also request an inspection by an accredited 
third party through PMAP, which was established on September 7, 2006. 
As of January 11, 2008, two inspections had been conducted by an 
accredited organization through PMAP, which is more limited than the 
Accredited Persons Inspection Program. The small number of inspections 
completed to date by accredited third-party organizations raises 
questions about the practicality and effectiveness of establishing 
similar programs that rely on third parties to help FDA fulfill other 
responsibilities. 

Background: 

FDA is responsible for overseeing the safety and effectiveness of 
medical devices that are marketed in the United States, whether 
manufactured in domestic or foreign establishments. All establishments 
that manufacture medical devices for marketing in the United States 
must register with FDA.[Footnote 18] As part of its efforts to ensure 
the safety, effectiveness, and quality of medical devices, FDA is 
responsible for inspecting certain domestic and foreign establishments 
to ensure that they meet manufacturing standards established in FDA's 
quality system regulation.[Footnote 19] FDA does not have authority to 
require foreign establishments to allow the agency to inspect their 
facilities. However, FDA has the authority to prevent the importation 
of products manufactured at establishments that refuse to allow an FDA 
inspection.[Footnote 20] Unlike food, for which FDA primarily relies on 
inspections at the border, physical inspection of manufacturing 
establishments is a critical mechanism in FDA's process to ensure that 
medical devices and drugs are safe and effective and that manufacturers 
adhere to good manufacturing practices. 

Within FDA, CDRH assures the safety and effectiveness of medical 
devices. Among other things, CDRH works with ORA, which conducts 
inspections of both domestic and foreign establishments to ensure that 
devices are produced in conformance with federal statutes and 
regulations, including the quality system regulation. FDA may conduct 
inspections before and after medical devices are approved or otherwise 
cleared to be marketed in the United States. 

* Premarket inspections are conducted before FDA will approve U.S. 
marketing of a new medical device that is not substantially equivalent 
to one that is already on the market.[Footnote 21] Premarket 
inspections primarily assess manufacturing facilities, methods, and 
controls and may verify pertinent records. 

* Postmarket inspections are conducted after a medical device has been 
approved or otherwise cleared to be marketed in the United States and 
include several types of inspections: (1) Quality system inspections 
are conducted to assess compliance with applicable FDA regulations, 
including the quality system regulation to ensure good manufacturing 
practices and the regulation requiring reporting of adverse 
events.[Footnote 22] These inspections may be comprehensive or 
abbreviated, which differ in the scope of inspectional activity. 
Comprehensive postmarket inspections assess multiple aspects of the 
manufacturer's quality system, including management controls, design 
controls, corrective and preventative actions, and production and 
process controls. Abbreviated postmarket inspections assess only some 
of these aspects, but always assess corrective and preventative 
actions. (2) For-cause and compliance follow-up inspections are 
initiated in response to specific information that raises questions or 
problems associated with a particular establishment. (3) Postmarket 
audit inspections are conducted within 8 to 12 months of a premarket 
application's approval to examine any changes in the design, 
manufacturing process, or quality assurance systems. 

FDA determines which establishments to inspect using a risk-based 
strategy. High priority inspections include premarket approval 
inspections for class III devices, for-cause inspections, inspections 
of establishments that have had a high frequency of device recalls, and 
other devices and manufacturers FDA considers high risk. The 
establishment's inspection history may also be considered. A provision 
in FDAAA may assist FDA in making decisions about which establishments 
to inspect because it authorizes the agency to accept voluntary 
submissions of audit reports addressing manufacturers' conformance with 
internationally established standards for the purpose of setting risk- 
based inspectional priorities.[Footnote 23] 

FDA's programs for domestic and foreign inspections by accredited third 
parties provide an alternative to the traditional FDA-conducted 
comprehensive postmarket quality system inspection for eligible 
manufacturers of class II and III medical devices. MDUFMA required FDA 
to accredit third persons--which are organizations--to conduct 
inspections of certain establishments. In describing this requirement, 
the House of Representatives Committee on Energy and Commerce noted 
that some manufacturers have faced an increase in the number of 
inspections required by foreign countries, and that the number of 
inspections could be reduced if the manufacturers could contract with a 
third-party organization to conduct a single inspection that would 
satisfy the requirements of both FDA and foreign countries.[Footnote 
24] Manufacturers that meet eligibility requirements may request a 
postmarket inspection by an FDA-accredited organization.[Footnote 25] 
The eligibility criteria for requesting an inspection of an 
establishment by an accredited organization include that the 
manufacturer markets (or intends to market) a medical device in a 
foreign country and the establishment to be inspected must not have 
received warnings for significant deviations from compliance 
requirements on its last inspection.[Footnote 26] 

MDUFMA also established minimum requirements for organizations to be 
accredited to conduct third-party inspections, including protecting 
against financial conflicts of interest and ensuring the competence of 
the organization to conduct inspections. FDA developed a training 
program for inspectors from accredited organizations that involves both 
formal classroom training and completion of three joint training 
inspections with FDA. Each individual inspector from an accredited 
organization must complete all training requirements successfully 
before being cleared to conduct independent inspections. FDA relies on 
manufacturers to volunteer to host these joint inspections, which count 
as FDA postmarket quality system inspections. 

A manufacturer that is cleared to have an inspection by an accredited 
third party enters an agreement with the approved accredited 
organization and schedules an inspection. Once the accredited 
organization completes its inspection, it prepares a report and submits 
it to FDA, which makes the final assessment of compliance with 
applicable requirements. FDAAA added a requirement that accredited 
organizations notify FDA of any withdrawal, suspension, restriction, or 
expiration of certificate of conformance with quality systems standards 
(such as those established by the International Organization for 
Standardization) for establishments they inspected for FDA.[Footnote 
27] 

In addition to the Accredited Persons Inspection Program, FDA has a 
second program for accredited third-party inspections of medical device 
establishments. On September 7, 2006, FDA and Health Canada announced 
the establishment of PMAP. This pilot program was designed to allow 
qualified third-party organizations to perform a single inspection that 
would meet the regulatory requirements of both the United States and 
Canada. The third-party organizations eligible to conduct inspections 
through PMAP are those that FDA accredited for its Accredited Persons 
Inspection Program (and that completed all required training for that 
program) and that are also authorized to conduct inspections of medical 
device establishments for Health Canada. To be eligible to have a third-
party inspection through PMAP, manufacturers must meet all criteria 
established for the Accredited Persons Inspection Program. As with the 
Accredited Persons Inspection Program, manufacturers must apply to 
participate and be willing to pay an accredited organization to conduct 
the inspection. 

FDA relies on multiple databases to manage its program for inspecting 
medical device manufacturing establishments. 

* DRLS contains information on domestic and foreign medical device 
establishments that have registered with FDA. Establishments that are 
involved in the manufacture of medical devices intended for commercial 
distribution in the United States are required to register annually 
with FDA. These establishments provide information to FDA, such as 
establishment name and address and the medical devices they 
manufacture. As of October 1, 2007, establishments are required to 
register electronically through FDA's Unified Registration and Listing 
System and certain medical device establishments pay an annual 
establishment registration fee, which in fiscal year 2008 is 
$1,706.[Footnote 28] 

* OASIS contains information on medical devices and other FDA-regulated 
products imported into the United States, including information on the 
establishment that manufactured the medical device. The information in 
OASIS is automatically generated from data managed by U.S. Customs and 
Border Protection, which are originally entered by customs brokers 
based on the information available from the importer.[Footnote 29] 

* FACTS contains information on FDA's inspections, including those of 
domestic and foreign medical device establishments. FDA investigators 
enter information into FACTS following completion of an inspection. 

According to FDA data, more than 23,600 establishments that manufacture 
medical devices were registered as of September 2007, of which 10,600 
reported that they manufacture class II or III medical 
devices.[Footnote 30] More than half--about 5,600--of these 
establishments were located in the United States. As of September 2007, 
there were more registered establishments in China and Germany 
reporting that they manufacture class II or III medical devices than in 
any other foreign countries.[Footnote 31] Canada, Taiwan, and the 
United Kingdom also had a large number of registered establishments. 
(See fig. 1.) Registered foreign establishments reported that they 
manufacture a variety of class II and III medical devices for the U.S. 
market. For example, common class III medical devices included coronary 
stents,[Footnote 32] pacemakers, and contact lenses. 

Figure 1: Registered Establishments That Reported Manufacturing Class 
II or Class III Medical Devices for the U.S. Market, by Country, 
September 2007: 

[See PDF for image] 

This figure is a map of the world, with shading indicating registered 
establishments that reported manufacturing Class II or Class III 
medical devices for the U.S. market, by country, September 2007. There 
are five classifications of shading as follows: 

Establishment count of 0; 
Establishment count of 1 to 50; 
Establishment count of 51 to 100; 
Establishment count of 101 to 200; and; 
Establishment count of 201 or more; included in this group are the 
following countries, with their establishment count: 
* United States: 5,616; 
* China: 675; 
* Germany: 581;
* United Kingdom: 351; 
* Taiwan: 349; 
* Canada: 340; 
* Japan: 264; 
* South Korea: 240; 
* Italy: 202. 

Source: GAO analysis of FDA data. 

Note: Counts of registered establishments in China do not include 
establishments registered in Hong Kong or Taiwan as these 
establishments are tracked separately in DRLS. In addition, DRLS 
contained one additional registered establishment for which location 
information was not available. 

[End of figure] 

FDA Is Not Inspecting Domestic Establishments Biennially as Required 
and Faces Challenges in Inspecting Foreign Establishments: 

FDA has not met the statutory requirement to inspect domestic 
establishments manufacturing class II or III medical devices every 2 
years. The agency conducted relatively few inspections of foreign 
establishments. The databases that provide FDA with data about the 
number of foreign establishments manufacturing medical devices for the 
U.S. market contain inaccuracies. In addition, inspections of foreign 
medical device manufacturing establishments pose unique challenges to 
FDA--both in human resources and logistics. 

FDA Is Not Inspecting Domestic Establishments Biennially and Inspects 
Relatively Few Foreign Establishments: 

From fiscal year 2002 through fiscal year 2007, FDA primarily inspected 
establishments located in the United States, where more than half of 
the 10,600 registered establishments that reported manufacturing class 
II or III medical devices are located. In contrast, FDA inspected 
relatively few foreign medical device establishments. During this 
period, FDA conducted an average of 1,494 domestic and 247 foreign 
establishment inspections each year.[Footnote 33] This suggests that 
each year FDA inspects about 27 percent of registered domestic 
establishments that reported manufacturing class II or class III 
medical devices and about 5 percent of such foreign establishments. The 
inspected establishments were in the United States and 44 foreign 
countries. Of the foreign inspections, more than two-thirds were in 10 
countries. Most of the countries with the highest number of inspections 
were also among those with the largest number of registered 
establishments that reported manufacturing class II or III medical 
devices. The lowest rate of inspections in these 10 countries was in 
China, where 64 inspections were conducted in this 6-year period and 
almost 700 establishments were registered. (See table 1.) 

Table 1: Number of FDA Inspections of Medical Device Establishments, 
Fiscal Year 2002 through Fiscal Year 2007: 

Country: United States; 
Number of inspections[A]: FY2002: 1,261; 
Number of inspections[A]: FY2003: 1,736; 
Number of inspections[A]: FY2004: 1,631; 
Number of inspections[A]: FY2005: 1,471; 
Number of inspections[A]: FY2006: 1,501; 
Number of inspections[A]: FY2007: 1,362; 
Number of inspections[A]: Total: 8,962[C]; 
Number of registered class II or III manufacturing establishments[B]: 
5,616. 

Country: Germany; 
Number of inspections[A]: FY2002: 39; 
Number of inspections[A]: FY2003: 30; 
Number of inspections[A]: FY2004: 34; 
Number of inspections[A]: FY2005: 51; 
Number of inspections[A]: FY2006: 25; 
Number of inspections[A]: FY2007: 52; 
Number of inspections[A]: Total: 231; 
Number of registered class II or III manufacturing establishments[B]: 
581. 

Country: United Kingdom; 
Number of inspections[A]: FY2002: 25; 
Number of inspections[A]: FY2003: 31; 
Number of inspections[A]: FY2004: 28; 
Number of inspections[A]: FY2005: 14; 
Number of inspections[A]: FY2006: 25; 
Number of inspections[A]: FY2007: 43; 
Number of inspections[A]: Total: 166; 
Number of registered class II or III manufacturing establishments[B]: 
351. 

Country: Canada; 
Number of inspections[A]: FY2002: 17; 
Number of inspections[A]: FY2003: 17; 
Number of inspections[A]: FY2004: 24; 
Number of inspections[A]: FY2005: 11; 
Number of inspections[A]: FY2006: 13; 
Number of inspections[A]: FY2007: 26; 
Number of inspections[A]: Total: 108; 
Number of registered class II or III manufacturing establishments[B]: 
340. 

Country: Japan; 
Number of inspections[A]: FY2002: 7; 
Number of inspections[A]: FY2003: 8; 
Number of inspections[A]: FY2004: 20; 
Number of inspections[A]: FY2005: 21; 
Number of inspections[A]: FY2006: 16; 
Number of inspections[A]: FY2007: 25; 
Number of inspections[A]: Total: 97; 
Number of registered class II or III manufacturing establishments[B]: 
264. 

Country: Ireland; 
Number of inspections[A]: FY2002: 15; 
Number of inspections[A]: FY2003: 22; 
Number of inspections[A]: FY2004: 13; 
Number of inspections[A]: FY2005: 13; 
Number of inspections[A]: FY2006: 16; 
Number of inspections[A]: FY2007: 11; 
Number of inspections[A]: Total: 90; 
Number of registered class II or III manufacturing establishments[B]: 
67. 

Country: France; 
Number of inspections[A]: FY2002: 16; 
Number of inspections[A]: FY2003: 14; 
Number of inspections[A]: FY2004: 17; 
Number of inspections[A]: FY2005: 14; 
Number of inspections[A]: FY2006: 12; 
Number of inspections[A]: FY2007: 10; 
Number of inspections[A]: Total: 83; 
Number of registered class II or III manufacturing establishments[B]: 
190. 

Country: Switzerland; 
Number of inspections[A]: FY2002: 6; 
Number of inspections[A]: FY2003: 12; 
Number of inspections[A]: FY2004: 19; 
Number of inspections[A]: FY2005: 9; 
Number of inspections[A]: FY2006: 7; 
Number of inspections[A]: FY2007: 18; 
Number of inspections[A]: Total: 71; 
Number of registered class II or III manufacturing establishments[B]: 
134. 

Country: China[D]; 
Number of inspections[A]: FY2002: 0; 
Number of inspections[A]: FY2003: 0; 
Number of inspections[A]: FY2004: 21; 
Number of inspections[A]: FY2005: 19; 
Number of inspections[A]: FY2006: 11; 
Number of inspections[A]: FY2007: 13; 
Number of inspections[A]: Total: 64; 
Number of registered class II or III manufacturing establishments[B]: 
675[E]. 

Country: Mexico; 
Number of inspections[A]: FY2002: 10; 
Number of inspections[A]: FY2003: 7; 
Number of inspections[A]: FY2004: 12; 
Number of inspections[A]: FY2005: 8; 
Number of inspections[A]: FY2006: 12; 
Number of inspections[A]: FY2007: 11; 
Number of inspections[A]: Total: 60; 
Number of registered class II or III manufacturing establishments[B]: 
143. 

Country: Italy; 
Number of inspections[A]: FY2002: 8; 
Number of inspections[A]: FY2003: 7; 
Number of inspections[A]: FY2004: 10; 
Number of inspections[A]: FY2005: 6; 
Number of inspections[A]: FY2006: 13; 
Number of inspections[A]: FY2007: 11; 
Number of inspections[A]: Total: 55; 
Number of registered class II or III manufacturing establishments[B]: 
202. 

Country: All other countries; 
Number of inspections[A]: FY2002: 66; 
Number of inspections[A]: FY2003: 83; 
Number of inspections[A]: FY2004: 102; 
Number of inspections[A]: FY2005: 67; 
Number of inspections[A]: FY2006: 69; 
Number of inspections[A]: FY2007: 69; 
Number of inspections[A]: Total: 456; 
Number of registered class II or III manufacturing establishments[B]: 
2,036. 

Country: Total; 
Number of inspections[A]: FY2002: 1,470; 
Number of inspections[A]: FY2003: 1,967; 
Number of inspections[A]: FY2004: 1,931; 
Number of inspections[A]: FY2005: 1,704; 
Number of inspections[A]: FY2006: 1,720; 
Number of inspections[A]: FY2007: 1,651; 
Number of inspections[A]: Total: 10,443; 
Number of registered class II or III manufacturing establishments[B]: 
10,600[F]. 

Source: GAO analysis of FDA data. 

[A] We were unable to differentiate inspections according to medical 
device classification. FDA's inspection database contains the most 
recent information available to FDA about the class of device 
manufactured at the establishment, and consequently does not contain 
readily available information about the class of devices manufactured 
at the time of a specific inspection. As a result, the data we present 
include all inspections, regardless of the classification of the 
manufactured device or devices. According to FDA officials, FDA 
primarily conducts inspections of establishments manufacturing class II 
or III medical devices. 

[B] These counts represent the number of registered establishments as 
of September 2007. 

[C] In addition to inspections conducted by FDA personnel, from fiscal 
year 2002 through fiscal year 2007, FDA contracted with states to 
conduct 164 quality system inspections. These inspections are not 
included in the total. 

[D] The inspection counts for China do not include inspections 
conducted in Hong Kong or Taiwan as these inspections are tracked 
separately in FACTS. 

[E] Counts of registered establishments in China do not include 
establishments registered in Hong Kong or Taiwan as these 
establishments are tracked separately in DRLS. 

[F] Registration numbers do not add to total because DRLS contained one 
additional registered establishment for which location information was 
not available. 

[End of table] 

Despite its focus on domestic inspections, FDA has not met the 
statutory requirement to inspect domestic establishments manufacturing 
class II or III medical devices every 2 years. For domestic 
establishments, FDA officials estimated that, on average, the agency 
inspects class II manufacturers every 5 years and class III 
manufacturers every 3 years. For foreign establishments--for which 
there is no comparable inspection requirement--FDA officials estimated 
that the agency inspects class II manufacturers every 27 years and 
class III manufacturers every 6 years. 

FDA's inspections of medical device establishments, both domestic and 
foreign, are primarily postmarket inspections. While premarket 
inspections are generally FDA's highest priority, relatively few have 
to be performed in any given year.[Footnote 34] Therefore, FDA focuses 
its resources on postmarket inspections. From fiscal year 2002 through 
fiscal year 2007, 95 percent of the 8,962 domestic establishment 
inspections and 89 percent of the 1,481 foreign establishment 
inspections were for postmarket purposes. (See fig. 2.) 

Figure 2: Number of Inspections of Domestic and Foreign Establishments 
That Manufacture Medical Devices for the U.S. Market, by Type of 
Inspection, Fiscal Year 2002 through Fiscal Year 2007: 

[See PDF for image] 

This figure is a vertical bar graph, depicting the following data: 

Location of inspected establishment: domestic; 
Premarket inspections: 430; 
Postmarket inspections: 8,532. 

Location of inspected establishment: foreign; 
Premarket inspections: 164; 
Postmarket inspections: 1,317. 

Source: GAO analysis of FDA data. 

Note: If an inspection had both premarket and postmarket components, we 
classified it as a premarket inspection. Of the 430 domestic premarket 
inspections, 256 contained both premarket and postmarket components. Of 
the 164 foreign premarket inspections, 95 contained both premarket and 
postmarket components. FDA may conduct other types of inspections--such 
as a postmarket quality system, compliance follow-up, for-cause, or 
postmarket audit inspection--at the same establishment at which they 
are conducting a premarket inspection. These inspections may focus on 
different products manufactured at the same establishment. 

[End of figure] 

FDA's Databases Provide Inconsistent Information Regarding the Number 
of Foreign Medical Device Manufacturing Establishments Subject to 
Inspection: 

FDA's databases on registration and imported products provide divergent 
estimates regarding the number of foreign medical device manufacturing 
establishments. DRLS provides FDA with information about domestic and 
foreign medical device establishments and the products they manufacture 
for the U.S. market. According to DRLS, as of September 2007, 5,616 
domestic and 4,983 foreign establishments that reported manufacturing a 
class II or III medical device for the U.S. market had registered with 
FDA.[Footnote 35] However, these data contain inaccuracies because 
establishments may register with FDA but not actually manufacture a 
medical device or may manufacture a medical device that is not marketed 
in the United States. FDA officials told us that their more frequent 
inspections of domestic establishments allow them to more easily update 
information about whether a domestic establishment is subject to 
inspection. 

In addition to DRLS, FDA obtains information on foreign establishments 
from OASIS, which tracks the import of medical devices. While not 
intended to provide a count of establishments, OASIS does contain 
information about the medical devices actually being imported into the 
United States and the establishments manufacturing them. However, 
inaccuracies in OASIS prevent FDA from using it to develop a list of 
establishments subject to inspection. OASIS contains duplicate records 
for a single establishment because of inaccurate data entry by customs 
brokers at the border. According to OASIS, in fiscal year 2007, there 
were as many as 22,008 foreign establishments that manufactured class 
II medical devices for the U.S. market and 3,575 foreign establishments 
that manufactured class III medical devices for the U.S. 
market.[Footnote 36] Despite the divergent estimates of foreign 
establishments generated by DRLS and OASIS, FDA does not routinely 
verify the data within each database. Although comparing information 
from these two databases could help FDA determine the number of foreign 
establishments marketing medical devices in the United States, the 
databases cannot exchange information to be compared electronically and 
any comparisons are done manually. 

Efforts are underway that could improve FDA's databases. FDA officials 
suggested that, because manufacturers are now required to pay an annual 
establishment registration fee, manufacturers may be more concerned 
about the accuracy of the registration data they submit. They also told 
us that, because of the registration fee, manufacturers may be less 
likely to register if they do not actually manufacture a medical device 
for the U.S. market. In addition, FDA officials stated that the agency 
is pursuing various initiatives to try to address the inaccuracies in 
OASIS, such as providing a unique identifier for each foreign 
establishment to reduce duplicate entries for individual 
establishments. 

Challenges Unique to Foreign Inspections Influence the Manner in Which 
FDA Conducts Such Inspections: 

Inspections of foreign establishments pose unique challenges to FDA-- 
both in human resources and logistics. FDA does not have a dedicated 
cadre of investigators that only conduct foreign medical device 
establishment inspections; those staff who inspect foreign 
establishments also inspect domestic establishments. Among those 
qualified to inspect foreign establishments,[Footnote 37] FDA relies on 
staff to volunteer to conduct inspections. FDA officials told us that 
it is difficult to recruit investigators to voluntarily travel to 
certain countries. However, they added that if the agency could not 
find an individual to volunteer for a foreign inspection trip, it would 
mandate the travel. Logistically, foreign medical device establishment 
inspections are difficult to extend even if problems are identified 
because the trips are scheduled in advance.[Footnote 38] Foreign 
medical device establishment inspections are also logistically 
challenging because investigators do not receive independent 
translational support from FDA or the State Department and may rely on 
English-speaking employees of the inspected establishment or the 
establishment's U.S. agent to translate during an inspection. 

Few Third-Party Inspections Are Conducted, but Recent Changes Could 
Eliminate Some Obstacles to Manufacturers' Participation: 

Few inspections of medical device manufacturing establishments have 
been conducted through FDA's two accredited third-party inspection 
programs--the Accredited Persons Inspection Program and PMAP. FDAAA 
specified several changes to the requirements for inspections by 
accredited third parties that could result in increased participation 
by manufacturers. 

Few inspections have been conducted through FDA's Accredited Persons 
Inspection Program since March 11, 2004--the date when FDA first 
cleared an accredited organization to conduct independent inspections. 
Through January 11, 2008, five inspections had been conducted 
independently by accredited organizations (two inspections of domestic 
establishments and three inspections of foreign establishments), an 
increase of three since we reported on this program one year 
ago.[Footnote 39] 

As of January 11, 2008, 16 third-party organizations were accredited, 
[Footnote 40] and individuals from 8 of these organizations had 
completed FDA's training requirements and been cleared to conduct 
independent inspections.[Footnote 41] As of January 8, 2008, FDA and 
accredited organizations had conducted 44 joint training 
inspections.[Footnote 42] Fewer manufacturers volunteered to host 
training inspections than have been needed for all of the accredited 
organizations to complete their training.[Footnote 43] Moreover, 
scheduling these joint training inspections has been difficult. FDA 
officials told us that, when appropriate, staff are instructed to ask 
manufacturers to host a joint training inspection at the time they 
notify the manufacturers of a pending inspection. FDA schedules 
inspections a relatively short time prior to an actual 
inspection,[Footnote 44] and as we reported in January 2007, some 
accredited organizations have not been able to participate because they 
had prior commitments. 

As we reported in January 2007, manufacturers' decisions to request an 
inspection by an accredited organization might be influenced by both 
potential incentives and disincentives. According to FDA officials and 
representatives of affected entities, potential incentives to 
participation include the opportunity to reduce the number of 
inspections conducted to meet FDA and other countries' requirements. 
For example, one inspection conducted by an accredited organization was 
a single inspection designed to meet the requirements of FDA, the 
European Union, and Canada. Another potential incentive mentioned by 
FDA officials and representatives of affected entities is the 
opportunity to control the scheduling of the inspection by an 
accredited organization by working with the accredited organization. 
FDA officials and representatives of affected entities also mentioned 
potential disincentives to having an inspection by an accredited 
organization. These potential disincentives include bearing the cost 
for the inspection,[Footnote 45] doubts about whether accredited 
organizations can cover multiple requirements in a single inspection, 
and uncertainty about the potential consequences of an inspection that 
otherwise may not occur in the near future--consequences that could 
involve regulatory action. 

Changes specified by FDAAA have the potential to eliminate certain 
obstacles to manufacturers' participation in FDA's programs for 
inspections by accredited third parties that were associated with 
manufacturers' eligibility. For example, an eligibility requirement 
that foreign establishments be periodically inspected by FDA was 
eliminated. Representatives of the two organizations that represent 
medical device manufacturers with whom we spoke about FDAAA told us 
that the changes in eligibility requirements could eliminate certain 
obstacles and therefore potentially increase their participation. These 
representatives also noted that key incentives and disincentives to 
manufacturers' participation remain. FDA officials told us that they 
are currently revising their guidance to industry in light of FDAAA and 
expect to issue the revised guidance during fiscal year 2008. It is too 
soon to tell what impact these changes will have on manufacturers' 
participation. 

FDA officials acknowledged that manufacturers' participation in the 
Accredited Persons Inspection Program has been limited. In December 
2007, FDA established a working group to assess the successes and 
failures of this program and to identify ways to increase 
participation. Representatives of the two organizations that represent 
medical device manufacturers with whom we recently spoke stated that 
they believe manufacturers remain interested in the Accredited Persons 
Inspection Program. The representative of one large, global 
manufacturer of medical devices told us that it is in the process of 
arranging to have 20 of its domestic and foreign device manufacturing 
establishments inspected by accredited third parties. 

As of January 11, 2008, two inspections, both of domestic 
establishments, had been conducted through PMAP, FDA's second program 
for inspections by accredited third parties. Although it is too soon to 
tell what the benefits of PMAP will be, the program is more limited 
than the Accredited Persons Inspection Program and may pose additional 
disincentives to participation by both manufacturers and accredited 
organizations. Specifically, inspections through PMAP would be designed 
to meet the requirements of the United States and Canada, whereas 
inspections conducted through the Accredited Persons Inspection Program 
could be designed to meet the requirements of other countries. In 
addition, two of the five representatives of affected entities noted 
that in contrast to inspections conducted through the Accredited 
Persons Inspection Program, inspections conducted through PMAP could 
undergo additional review by Health Canada. Health Canada will review 
inspection reports submitted through this pilot program to ensure they 
meet its standards. This extra review poses a greater risk of 
unexpected outcomes for the manufacturer and the accredited 
organization, which could be a disincentive to participation in PMAP 
that is not present with the Accredited Persons Inspection Program. 

Concluding Observations: 

Americans depend on FDA to ensure the safety and effectiveness of 
medical products, including medical devices, manufactured throughout 
the world. However, our findings regarding inspections of medical 
device manufacturers indicate weaknesses that mirror those presented in 
our November 2007 testimony regarding inspections of foreign drug 
manufacturers. In addition, they are consistent with the FDA Science 
Board's findings that FDA's ability to fulfill its regulatory 
responsibilities is jeopardized, in part, by information technology and 
human resources challenges. We recognize that FDA has expressed the 
intention to improve its data management, but it is too early to tell 
whether the intended changes will ultimately enhance the agency's 
ability to manage its inspection programs. We and others have suggested 
that the use of accredited third parties could improve FDA's ability to 
meet its inspection responsibilities. However, the implementation of 
its programs for inspecting medical device manufacturers has resulted 
in little progress. To date, its programs for inspections by accredited 
third parties have not assisted FDA in meeting its regulatory 
responsibilities nor have they provided a rapid or substantial increase 
in the number of inspections performed by these organizations, as 
originally intended. Although recent statutory changes to the 
requirements for inspections by accredited third parties may encourage 
greater participation in these programs, the lack of meaningful 
progress raises questions about the practicality and effectiveness of 
establishing similar programs that rely on third parties to quickly 
help FDA fulfill other responsibilities. 

Mr. Chairman, this completes my prepared statement, I would be happy to 
respond to any questions you or the other Members of the subcommittee 
may have at this time. 

Contacts and Acknowledgments: 

For further information about this testimony, please contact Marcia 
Crosse at (202) 512-7114 or [email protected]. Contact points for our 
Offices of Congressional Relations and Public Affairs may found on the 
last page of this testimony. Geraldine Redican-Bigott, Assistant 
Director; Kristen Joan Anderson; Katherine Clark; Robert Copeland; 
William Hadley; Cathy Hamann; Mollie Hertel; Julian Klazkin; Lisa 
Motley; Daniel Ries; and Suzanne Worth made key contributions to this 
testimony. 

[End of section] 

Appendix I: Summary of GAO Testimony on FDA's Program for Inspecting 
Foreign Drug Manufacturers: 

In congressional testimony in November 2007, we presented our 
preliminary findings on the Food and Drug Administration's (FDA) 
program for inspecting foreign drug manufacturers.[Footnote 46] We 
found that (1) FDA's effectiveness in managing the foreign drug 
inspection program continued to be hindered by weaknesses in its 
databases; (2) FDA inspected relatively few foreign establishments; and 
(3) the foreign inspection process involved unique circumstances that 
were not encountered domestically. 

Our preliminary findings indicated that more than 9 years after we 
issued our last report on FDA's foreign drug inspection program, 
[Footnote 47] FDA's effectiveness in managing this program 
continued to be hindered by weaknesses in its databases. FDA did not 
know how many foreign establishments were subject to inspection. 
Instead of maintaining a list of such establishments, FDA relied on 
information from several databases that were not designed for this 
purpose. One of these databases contained information on foreign 
establishments that had registered to market drugs in the United 
States, while another contained information on drugs imported into the 
United States. One database indicated about 3,000 foreign 
establishments could have been subject to inspection in fiscal year 
2007, while another indicated that about 6,800 foreign establishments 
could have been subject to inspection in that year. Despite the 
divergent estimates of foreign establishments subject to inspection 
generated by these two databases, FDA did not verify the data within 
each database. For example, the agency did not routinely confirm that a 
registered establishment actually manufactured a drug for the U.S. 
market. However, FDA used these data to generate a list of 3,249 
foreign establishments from which it prioritized establishments for 
inspection. 

Because FDA was not certain how many foreign drug establishments were 
actually subject to inspection, the percentage of such establishments 
that had been inspected could not be calculated with certainty. We 
found that FDA inspected relatively few foreign drug establishments, as 
shown in table 2. Using the list of 3,249 foreign drug establishments 
from which FDA prioritized establishments for inspection, we found that 
the agency may inspect about 7 percent of foreign drug establishments 
in a given year. At this rate, it would take FDA more than 13 years to 
inspect each foreign drug establishment on this list once, assuming 
that no additional establishments are subject to inspection. 

Table 2: Number of FDA Inspections of Foreign Establishments Involved 
in the Manufacture of Drugs for the U.S. Market, Fiscal Year 2002 
through Fiscal Year 2007: 

Country: India; 
Number of inspections: FY2002: 11; 
Number of inspections: FY2003: 19; 
Number of inspections: FY2004: 38; 
Number of inspections: FY2005: 33; 
Number of inspections: FY2006: 34; 
Number of inspections: FY2007[A]: 65; 
Number of inspections: Total: 200; 
Number of establishments[B]: 410. 

Country: Germany; 
Number of inspections: FY2002: 24; 
Number of inspections: FY2003: 15; 
Number of inspections: FY2004: 35; 
Number of inspections: FY2005: 25; 
Number of inspections: FY2006: 19; 
Number of inspections: FY2007[A]: 22; 
Number of inspections: Total: 140; 
Number of establishments[B]: 199. 

Country: Italy; 
Number of inspections: FY2002: 17; 
Number of inspections: FY2003: 30; 
Number of inspections: FY2004: 26; 
Number of inspections: FY2005: 21; 
Number of inspections: FY2006: 18; 
Number of inspections: FY2007[A]: 19; 
Number of inspections: Total: 131; 
Number of establishments[B]: 150. 

Country: Canada; 
Number of inspections: FY2002: 29; 
Number of inspections: FY2003: 12; 
Number of inspections: FY2004: 17; 
Number of inspections: FY2005: 23; 
Number of inspections: FY2006: 23; 
Number of inspections: FY2007[A]: 19; 
Number of inspections: Total: 123; 
Number of establishments[B]: 288. 

Country: United Kingdom; 
Number of inspections: FY2002: 19; 
Number of inspections: FY2003: 22; 
Number of inspections: FY2004: 15; 
Number of inspections: FY2005: 18; 
Number of inspections: FY2006: 15; 
Number of inspections: FY2007[A]: 13; 
Number of inspections: Total: 102; 
Number of establishments[B]: 169. 

Country: France; 
Number of inspections: FY2002: 14; 
Number of inspections: FY2003: 15; 
Number of inspections: FY2004: 13; 
Number of inspections: FY2005: 12; 
Number of inspections: FY2006: 16; 
Number of inspections: FY2007[A]: 24; 
Number of inspections: Total: 94; 
Number of establishments[B]: 162. 

Country: China; 
Number of inspections: FY2002: 11; 
Number of inspections: FY2003: 9; 
Number of inspections: FY2004: 17; 
Number of inspections: FY2005: 21; 
Number of inspections: FY2006: 17; 
Number of inspections: FY2007[A]: 13; 
Number of inspections: Total: 88; 
Number of establishments[B]: 714. 

Country: Japan; 
Number of inspections: FY2002: 11; 
Number of inspections: FY2003: 13; 
Number of inspections: FY2004: 14; 
Number of inspections: FY2005: 21; 
Number of inspections: FY2006: 13; 
Number of inspections: FY2007[A]: 15;
Number of inspections: Total: 87; 
Number of establishments[B]: 196. 

Country: Switzerland; 
Number of inspections: FY2002: 12; 
Number of inspections: FY2003: 12; 
Number of inspections: FY2004: 11; 
Number of inspections: FY2005: 17; 
Number of inspections: FY2006: 9; 
Number of inspections: FY2007[A]: 14;
Number of inspections: Total: 75; 
Number of establishments[B]: 83. 

Country: Ireland; 
Number of inspections: FY2002: 11; 
Number of inspections: FY2003: 5; 
Number of inspections: FY2004: 11; 
Number of inspections: FY2005: 14; 
Number of inspections: FY2006: 3; 
Number of inspections: FY2007[A]: 11; 
Number of inspections: Total: 55; 
Number of establishments[B]: 61. 

Country: All other countries; 
Number of inspections: FY2002: 63; 
Number of inspections: FY2003: 38; 
Number of inspections: FY2004: 63; 
Number of inspections: FY2005: 61; 
Number of inspections: FY2006: 45; 
Number of inspections: FY2007[A]: 80; 
Number of inspections: Total: 350; 
Number of establishments[B]: 817. 

Country: Total; 
Number of inspections: FY2002: 222; 
Number of inspections: FY2003: 190; 
Number of inspections: FY2004: 260; 
Number of inspections: FY2005: 266; 
Number of inspections: FY2006: 212;
Number of inspections: FY2007[A]: 295; 
Number of inspections: Total: 1,445; 
Number of establishments[B]: 3,249. 

Source: GAO analysis of FDA data. 

[A] Inspection data for fiscal year 2007 may not be complete because 
FDA provided these data as of September 26, 2007, prior to the end of 
the fiscal year. 

[B] This count represents the number of establishments FDA used to plan 
its fiscal year 2007 prioritized surveillance inspections. 

[End of table] 

FDA's data indicated that some foreign drug manufacturers had not 
received an inspection, but FDA could not provide the exact number of 
foreign drug establishments that had never been inspected. Most of the 
foreign drug inspections were conducted as part of processing a new 
drug application or an abbreviated new drug application,[Footnote 48] 
rather than as current good manufacturing practices (GMP) surveillance 
inspections, which are used to monitor the quality of marketed drugs. 
FDA used a risk-based process, based in part on data from its 
registration and import databases, to develop a prioritized list of 
foreign drug establishments for GMP surveillance inspections in fiscal 
year 2007. According to FDA, about 30 such inspections were completed 
in fiscal year 2007, and at least 50 were targeted for inspection in 
fiscal year 2008. Further, inaccuracies in the data on which this risk- 
based process depended limited its effectiveness. 

Finally, the very nature of the foreign drug inspection process 
involved unique circumstances that were not encountered domestically. 
For example, FDA did not have a dedicated staff to conduct foreign drug 
inspections and relied on those inspecting domestic establishments to 
volunteer for foreign inspections. While FDA may conduct unannounced 
GMP inspections of domestic establishments, it did not arrive 
unannounced at foreign establishments. It also lacked the flexibility 
to easily extend foreign inspections if problems were encountered due 
to the need to adhere to an itinerary that typically involved multiple 
inspections in the same country. Finally, language barriers can make 
foreign inspections more difficult to conduct than domestic ones. FDA 
did not generally provide translators to its inspection teams. Instead, 
they may have had to rely on an English-speaking representative of the 
foreign establishment being inspected, rather than an independent 
translator. 

[End of section] 

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. ï¿½ 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. ï¿½ 
807.3(c) (2007). Medical device manufacturers may have more than one 
establishment. We use the term "manufacture" to refer to activities 
including manufacturing, preparing, and processing devices. 

[3] 21 U.S.C. ï¿½ 360c. Medical devices are classified into one of three 
classes. Class I includes "low risk" devices, such as tongue 
depressors, elastic bandages, and bedpans. Class II includes "medium 
risk" devices, such as syringes, hearing aids, and electrocardiograph 
machines. Class III includes "high risk" devices, such as heart valves, 
pacemakers, and defibrillators. 

[4] 21 U.S.C. ï¿½ 360(h). There is no statutory requirement for 
inspection of class I medical device manufacturing establishments, and 
FDA does not routinely inspect them. However, FDA periodically inspects 
establishments manufacturing surgeon's gloves and patient examination 
gloves, which are both class I medical devices, due to ongoing problems 
with leakage. FDA also periodically inspects manufacturers of randomly 
selected class I devices. 

[5] See Pub. L. No. 107-250, ï¿½ 201, 116 Stat. 1588, 1602-09 (2002) 
(codified as amended at 21 U.S.C. ï¿½ 374(g)). 

[6] In this report, unless otherwise noted, when we discuss 
inspections, we are referring to those conducted by FDA investigators. 

[7] GAO, Medical Devices: Status of FDA's Program for Inspections by 
Accredited Organizations, GAO-07-157 (Washington, D.C.: Jan. 5, 2007). 

[8] Health Canada is the governmental entity that regulates medical 
devices marketed in Canada. 

[9] H.R. Rep. No. 107-728, pt. 1, at 35-36 (2002). 

[10] GAO, Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's 
Program for Inspecting Foreign Drug Manufacturers, GAO-08-224T 
(Washington, D.C.: Nov. 1, 2007). 

[11] The Science Board, which is an advisory board to the commissioner 
of FDA, provides advice on, among other things, specific complex and 
technical issues as well as emerging issues within the scientific 
community. 

[12] FDA Science Board, Subcommittee on Science and Technology, FDA 
Science and Mission at Risk (November 2007), [hyperlink, 
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-
4329b_02_00_index.html] (accessed Jan. 18, 2008). 

[13] In July 2007, the Interagency Working Group on Import Safety was 
established to conduct a comprehensive review of current import safety 
practices and determine where improvements could be made. Interagency 
Working Group on Import Safety, Action Plan for Import Safety: A 
roadmap for continual improvement (November 2007), [hyperlink, 
http://www.importsafety.gov/report/actionplan.pdf] (accessed Dec. 6, 
2007). 

[14] See GAO, Food Safety: FDA's Imported Seafood Safety Program Shows 
Some Progress, but Further Improvements are Needed, GAO-04-246 
(Washington, D.C.: Jan. 30, 2004). 

[15] GAO, Federal Oversight of Food Safety: FDA's Food Protection Plan 
Proposes Positive First Steps, but Capacity to Carry Them Out is 
Critical, GAO-08-435T (Washington, D.C.: Jan. 29, 2008). 

[16] Within FDA, the Center for Biologics Evaluation and Research 
regulates medical devices involved in human immunodeficiency virus 
(HIV) testing and the collection, processing, testing, manufacture, and 
administration of licensed blood, blood components, and cellular 
products. We did not include medical devices regulated by this center 
in the scope of our work. 

[17] These affected entities included accredited organizations, 
organizations that represent medical device manufacturers, and medical 
device manufacturers. 

[18] 21 U.S.C. ï¿½ 360(b), (i). 

[19] 21 C.F.R. pt. 820 (2007). The quality system regulation requires, 
among other things, that domestic or foreign manufacturers have a 
quality system in place to implement current good manufacturing 
practices in the design, manufacture, packaging, labeling, storage, 
installation, and servicing of finished medical devices intended for 
human use in the United States. A quality system includes the 
organizational structure, responsibilities, procedures, processes, and 
resources for implementing quality management. 

[20] See 21 U.S.C. ï¿½ 381(a); 21 C.F.R. ï¿½ 820.1(d) (2007). 

[21] Currently, most medical devices are cleared for marketing in the 
United States because they are "substantially equivalent" to a marketed 
device. FDA generally does not conduct premarket inspections of 
establishments manufacturing these types of medical devices. 

[22] 21 C.F.R. pt. 803 (2007). 

[23] Pub. L. No. 110-85, ï¿½ 228, 121 Stat. 858 (2007). 

[24] H.R. Rep. No. 107-728, pt. 1, at 32-36 (2002). Some foreign 
countries have accredited, certified, or otherwise recognized 
organizations to conduct inspections. We use the term "single 
inspection" to mean a complete inspection that covers all requirements 
of two or more countries, without repeating those activities covered 
under more than one set of requirements. A complete inspection can be 
conducted during a single block of time or in multiple phases. Two or 
more separate inspection reports could be generated on the basis of 
that single inspection. 

[25] Accredited organizations may conduct comprehensive postmarket 
quality system inspections, but not other types of inspections of 
establishments that FDA has the authority to conduct, such as premarket 
or for-cause inspections. FDA may conduct its own inspections of 
establishments even after inspection by an accredited organization. 

[26] 21 U.S.C. ï¿½ 374(g). FDAAA eliminated certain previously 
established eligibility requirements. For example, it eliminated a 
limitation on the number of consecutive inspections allowed by an 
accredited organization and a limitation that foreign establishments 
must be inspected periodically by FDA. 

[27] 21 U.S.C. ï¿½ 374(g)(3)(F). 

[28] 21 U.S.C. ï¿½ 379j(a)(3), (b). 

[29] Customs brokers are private individuals, partnerships, 
associations, or corporations licensed, regulated, and empowered by 
U.S. Customs and Border Protection to assist in meeting federal 
requirements governing imports and exports. 

[30] Throughout this testimony, we use DRLS data because FDA officials 
told us that the agency would continue to use those data, as available 
on September 19, 2007, until it is confident that all device 
establishments required to register have done so through the new 
electronic system, FDA's Unified Registration and Listing System. 

[31] Counts of registered establishments in China do not include 
establishments registered in Hong Kong or Taiwan as these 
establishments are tracked separately in DRLS. 

[32] A coronary stent is a small tube that is placed within a coronary 
artery to keep the vessel open. 

[33] We were unable to differentiate inspections according to medical 
device classification. FDA's inspection database contains the most 
recent information available to FDA about the class of device 
manufactured at the establishment, and consequently does not contain 
readily available information about the class of devices manufactured 
at the time of a specific inspection. As a result, the data we present 
include all inspections, regardless of the classification of the 
manufactured device or devices. According to FDA officials, FDA 
primarily conducts inspections of establishments manufacturing class II 
or III medical devices. 

[34] Currently, most medical devices are cleared for marketing in the 
United States because they are "substantially equivalent" to a marketed 
device. FDA generally does not conduct premarket inspections of 
establishments manufacturing these types of medical devices. 

[35] DRLS contained one additional registered establishment for which 
location information was not available. 

[36] According to FDA officials, a single establishment could be 
manufacturing more than one class of device. 

[37] Staff members must meet certain criteria in terms of their 
experience and training to conduct inspections of foreign 
establishments. For example, they are required to take certain training 
courses and have at least 3 years of experience conducting domestic 
inspections before they can be considered qualified to conduct a 
foreign inspection. 

[38] Typically, FDA investigators travel abroad for about 3 weeks at a 
time, during which they inspect approximately three establishments. 

[39] In January 2007, we reported that two inspections had been 
independently conducted by accredited organizations through the 
Accredited Persons Inspection Program--one inspection of a domestic 
establishment and one inspection of a foreign establishment. GAO-07-
157, 11. 

[40] FDA officials told us that no additional organizations have 
applied for accreditation since we issued our January 2007 report. 

[41] In January 2007, we reported that 7 of the 16 accredited 
organizations had been cleared to conduct independent inspections. GAO-
07-157, 11. One additional accredited organization was cleared to 
conduct independent inspections on October 18, 2007. Specific foreign 
jurisdictions that have certified, accredited, or otherwise recognized 
one or more of the FDA-accredited organizations that have been cleared 
to conduct independent inspections include all member states of the 
European Community, Australia, Canada, New Zealand, Norway, Taiwan, and 
the United Kingdom. Of the 8 third-party organizations that have been 
cleared to conduct independent inspections through the Accredited 
Persons Inspection Program, 4 may conduct inspections through PMAP. 

[42] In January 2007, we reported that FDA and accredited organizations 
had conducted 37 joint training inspections. GAO-07-157, 11. 

[43] As we reported in January 2007, some representatives of affected 
entities speculated that manufacturers might not have volunteered to 
host training inspections because they believed that training 
inspections would require more time and effort for their staff (and 
would thus be more disruptive) than inspections conducted by fully 
trained personnel, or that manufacturers might have believed that 
training inspections would be more rigorous than nontraining 
inspections if the trainees and FDA personnel were to take particular 
care to demonstrate their thoroughness to each other. 

[44] FDA generally notifies manufacturers about a week in advance of 
postmarket quality system inspections of domestic establishments and 
about 6 to 8 weeks in advance of postmarket quality system inspections 
of foreign establishments. 

[45] In January 2007, we reported that representatives of accredited 
organizations indicated that the cost to manufacturers would vary 
depending on such factors as the size of the manufacturer and how much 
extra time would be required to assess compliance with FDA 
requirements. Representatives suggested that covering FDA's 
requirements could take 2 or more days in addition to the time spent 
assessing other countries' requirements, plus time for advance 
preparation and writing the inspection report. They speculated that 
they would probably charge manufacturers from $1,700 to $2,500 per day, 
plus the cost of travel and living expenses. 

[46] GAO, Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's 
Program for Inspecting Foreign Drug Manufacturers, GAO-08-224T 
(Washington, D.C.: Nov. 1, 2007). 

[47] GAO, Food and Drug Administration: Improvements Needed in the 
Foreign Drug Inspection Program, GAO/HEHS-98-21 (Washington, D.C.: Mar. 
17, 1998). 

[48] FDA must approve a new drug application before a new drug product 
may be marketed in the United States; approval for a generic drug is 
sought through an abbreviated new drug application. FDA also reviews 
scientific and clinical data contained in the applications, as part of 
its process in considering them for approval to be marketed. 

[End of section] 

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