FDA failing to inspect medical device manufacturers
A GAO report (30-page PDF) reveals the FDA has not met the statutory requirement to inspect certain domestic establishments manufacturing high-risk medical devices every two years, and the agency faces challenges inspecting foreign 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.
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 three years (for high-risk devices) or five 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 six years (for high-risk devices) or 27 years (for medium-risk devices). FDA faces challenges in managing its inspections of foreign medical device establishments.
Finally, inspections of foreign medical device manufacturing establishments pose unique challenges to FDA in human resources and logistics.
(Jan. 29, 2008)