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;   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; and request and receive FDA’s approval to use a specific accredited  organization. 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 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. 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. FDA granted accreditation to the 15  organizations with the highest ranking applications, and denied  accreditation to the remaining 4 organizations with lower-ranking  applications. Two Inspections Independently Conducted by an Accredited Organization

Between March 11, 2004—the date when FDA first cleared an accredited  organization to conduct independent inspections of establishments—and  October 31, 2006, two accredited organizations conducted independent  inspections—one inspection of a domestic establishment and one  inspection of a foreign establishment. During the same time period, 36  inspections of domestic establishments and 1 inspection of a foreign  establishment were conducted by accredited organizations jointly with  FDA officials as part of the training FDA required of accredited  organizations. The remaining 9  accredited organizations had not completed all training requirements as of  October 31, 2006. Additional factors may influence manufacturers’  interest in participating in the program by hosting required training  inspections. Potential incentives to having an inspection by an accredited organization  include the opportunity to reduce the number of inspections conducted to  meet FDA and other countries’ requirements and to control the scheduling  of the inspection by an accredited organization. FDA and representatives of affected entities told us that the potential  disincentives to having an inspection by an accredited organization  include bearing the cost for the inspection, doubts about whether  accredited organizations can cover multiple requirements in a single  inspection, and uncertainty about the potential consequences of making a  commitment to having an inspection to assess compliance with FDA  requirements in the near future. Manufacturers 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. Agency Comments

We provided a draft of this report to the Department of Health and Human  Services for comment. Appendix I: Inspections Conducted by the Food and Drug Administration

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)  requires us to report on the number of inspections of medical device  establishments conducted by the Food and Drug Administration (FDA). 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. 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.
Why GAO Did This Study

The Food and Drug Administration (FDA) inspects domestic and foreign establishments where U.S.-marketed medical devices are manufactured to assess compliance with FDA's quality system requirements for ensuring good manufacturing practices and other applicable requirements. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) required FDA to accredit organizations to inspect certain establishments where devices that are marketed in both the United States and other countries are manufactured. This report includes information that MDUFMA requires GAO to provide on (1) the number of organizations that sought accreditation, the number that were accredited, and reasons for denial of accreditation and (2) the number of inspections conducted by accredited organizations. It also includes information about factors that could influence manufacturers' interest in voluntarily requesting and paying for an inspection by an accredited organization. GAO examined FDA documents, interviewed FDA officials, and obtained information from FDA on the number of inspections conducted from March 11, 2004--when FDA first cleared an accredited organization to conduct independent inspections--through October 31, 2006. GAO also interviewed affected entities, including accredited organizations and medical device manufacturers.

What GAO Found

FDA granted accreditation to 17 of 23 organizations that applied to conduct inspections of establishments where medical devices are manufactured. FDA denied accreditation to applicants that did not meet minimum criteria because their applications were not correctly completed or did not demonstrate the applicants' technical competence. During the first accreditation year, which started in April 2003, FDA received 23 applications. Of the 23 applications, 2 were not correctly completed and 2 did not demonstrate that the applicants had adequate technical competence. Although the remaining 19 applicants met the minimum criteria, MDUFMA limited the number of organizations that could be accredited to 15 during the first year after FDA issued criteria for accreditation. FDA scored the 19 applications against these criteria and rank-ordered them. It accredited the 15 organizations with the highest ranking applications, but 1 organization later withdrew. After the initial accreditation year, FDA received 2 more applications for accreditation and it accredited both organizations. These 16 organizations remained accredited as of October 31, 2006. Between March 11, 2004, and October 31, 2006, two accredited organizations conducted independent inspections--one inspection of a domestic establishment and one inspection of a foreign establishment. During that same period, 36 inspections of domestic establishments and 1 inspection of a foreign establishment were conducted by accredited organizations jointly with FDA officials as part of training that FDA requires of accredited organizations. As of October 31, 2006, individuals from 7 of the 16 accredited organizations had completed all training requirements and were cleared to conduct independent inspections. Several factors may influence manufacturers' interest in voluntarily requesting an inspection by an accredited organization. According to FDA and representatives of affected entities, there are potential incentives and disincentives to requesting an inspection, as well as reasons for deferring participation in the program. Potential incentives include the opportunity to reduce the number of inspections conducted to meet FDA and other countries' requirements and to control the scheduling of the inspection. Potential disincentives include bearing the cost for the inspection and uncertainty about the potential consequences of making a commitment to having an inspection to assess compliance with FDA requirements in the near future. Some manufacturers might be deferring participation. For example, manufacturers that already contract with a specific accredited organization to conduct inspections to meet the requirements of other countries might defer participation until FDA has cleared that organization to conduct independent inspections. The Department of Health and Human Services provided technical comments on a draft of this report, which GAO incorporated as appropriate.