As part of its efforts to ensure the safety,  effectiveness, and quality of medical devices, FDA is responsible for  inspecting certain foreign and domestic establishments to ensure that,  among other things, they meet manufacturing standards established in  FDA’s quality system regulation. 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. On September 7, 2006, FDA and Health Canada announced  the establishment of PMAP. These  establishments provide information to FDA, such as an establishment’s  name and its address and the medical devices it manufactures. FDA Faces Challenges Conducting Inspections of Foreign Establishments That Manufacture Medical Devices

FDA faces challenges in its program to inspect foreign establishments  manufacturing medical devices. FDA Lacks Accurate Data on the Number of Foreign Establishments Subject to Inspection, but Has Made Recent Attempts to Improve Its Data

FDA’s databases on registration and imported medical devices have not  provided an accurate count of establishments subject to inspection,  although recent improvements to FDA’s medical device registration  database may address some weaknesses. In January 2008, we testified that  DRLS provided FDA with information about foreign medical device  establishments and the products they manufacture for the U.S. market. FDA has solicited proposals for this contract, but it is still developing the  specifics of the program. FDA officials estimated the agency  had inspected foreign class II manufacturers every 27 years and foreign  class III manufacturers every 6 years. While the establishment of  both a foreign inspection cadre and offices overseas have the potential for  improving FDA’s oversight of foreign establishments, it is too early to tell  whether these steps will be effective or will increase the number of foreign  medical device establishment inspections. Few Inspections of Foreign Establishments Have Been Conducted Through FDA’s Third- Party Programs, but Recent Changes Could Eliminate Some Obstacles to Manufacturers’ Participation

Few inspections of foreign medical device manufacturing  establishments—a total of six—have been conducted through FDA’s two  accredited third-party inspection programs, the Accredited Persons  Inspection Program and PMAP. FDAAA specified several changes to the  requirements for inspections by accredited third parties that could result  in increased participation by manufacturers. Few inspections have been conducted through FDA’s Accredited Persons  Inspection Program since March 11, 2004—the date when FDA first  cleared an accredited organization to conduct independent inspections. Through May 7, 2008, four inspections of foreign establishments had been  conducted independently by accredited organizations. 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. These potential disincentives  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 an  inspection that otherwise may not occur in the near future—consequences  that could involve regulatory action. As of May 7, 2008, two inspections of foreign establishments had been  conducted through PMAP, FDA’s second program for inspections by  accredited third parties. However, the lack of meaningful progress  in conducting inspections to this point raises questions about the  practicality and effectiveness of these programs to help FDA conduct  additional foreign inspections. This is a work of the U.S. government and is not subject to copyright protection in the  United States.
Why GAO Did This Study

As part of the Food and Drug Administration's (FDA) oversight of the safety and effectiveness of medical devices marketed in the United States, it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement is based primarily on GAO testimonies from January 2008 (GAO-08-428T) and April 2008 (GAO-08-701T). In this statement, GAO assesses (1) FDA's program for inspecting foreign establishments that manufacture medical devices for the U.S. market and (2) FDA's programs for third-party inspections of those establishments. For GAO's January and April 2008 testimonies, GAO interviewed FDA officials, analyzed information from FDA, and updated GAO's previous work on FDA's programs for inspections by accredited third parties. GAO updated selected information for this statement in early May 2008.

What GAO Found

FDA faces challenges managing its program to inspect foreign establishments that manufacture medical devices. GAO testified in January 2008 that two databases that provide FDA with information about foreign medical device establishments and the products they manufacture for the U.S. market contained inaccurate information about establishments subject to FDA inspection. In addition, comparisons between these databases--which could help produce a more accurate count--had to be done manually. Recent changes FDA made to its registration database could improve the accuracy of the count of establishments, but it is too soon to tell whether these and other changes will improve FDA's management of its foreign inspection program. Another challenge is that FDA conducts relatively few inspections of foreign establishments; officials estimated that the agency inspects foreign manufacturers of high-risk devices (such as pacemakers) every 6 years and foreign manufacturers of medium-risk devices (such as hearing aids) every 27 years. Finally, inspections of foreign manufacturers pose unique challenges to FDA, such as difficulties in recruiting investigators to travel to certain countries and in extending trips if the inspections uncovered problems. FDA is pursuing initiatives that could address some of these unique challenges, but it is unclear whether FDA's proposals will increase the frequency with which the agency inspects foreign establishments. Few inspections of foreign medical device manufacturing establishments have been conducted through FDA's two accredited third-party inspection programs--the Accredited Persons Inspection Program and the Pilot Multi-purpose Audit Program (PMAP). Under FDA's Accredited Persons Inspection Program, from March 11, 2004--the date when FDA first cleared an accredited organization to conduct independent inspections--through May 7, 2008, four inspections of foreign establishments had been conducted by accredited organizations. An incentive to participation in the program is the opportunity to reduce the number of inspections conducted to meet FDA's and other countries' requirements. Disincentives include bearing the cost for the inspection, particularly when the consequences of an inspection that otherwise might not occur in the near future could involve regulatory action. The Food and Drug Administration Amendments Act of 2007 made several changes to program eligibility requirements that could result in increased participation by manufacturers. PMAP was established on September 7, 2006, as a partnership between FDA and Canada's medical device regulatory agency and allows accredited organizations to conduct a single inspection to meet the regulatory requirements of both countries. As of May 7, 2008, two inspections of foreign establishments had been conducted by accredited organizations through this program. The small number of inspections completed to date by accredited third-party organizations raises questions about the practicality and effectiveness of these programs to quickly help FDA increase the number of foreign establishments inspected.