All establishments that manufacture  medical devices for marketing in the United States must register with  FDA. 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. 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. In addition to the Accredited Persons Inspection Program, FDA has a  second program for accredited third-party inspections of medical device  establishments. More than  half—about 5,600—of these establishments were located in the United  States. 1.) 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 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. 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. 2.) 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. 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. 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. 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 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 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.
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 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.

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 FDA's two accredited third-party inspection programs--the Accredited Persons Inspection Program and the Pilot Multi-purpose Audit Program (PMAP). From March 11, 2004--the date when FDA first cleared an accredited organization to conduct independent inspections--through January 11, 2008, five inspections have been conducted by accredited organizations through FDA's 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 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, 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.