Skip to Highlights
Highlights

GAO discussed the Food and Drug Administration's Good Manufacturing Practices (GMP) Compliance Program for medical devices. GAO noted that: (1) in order to prevent the production and distribution of unsafe and ineffective medical devices, the GMP Compliance Program assesses manufacturers' implementation of the quality assurance requirements; (2) FDA continues to develop more stringent GMP quality assurance criteria and is working to harmonize GMP requirements with international quality assurance standards; (3) between fiscal years (FY) 1987 and 1989, the total number of device GMP inspections and the number of qualified inspections steadily declined, primarily due to the FDA prioritized inspection policy; (4) between FY 1987 and 1990, FDA untimely inspected one-third of the 323 manufacturers that initiated the first recall of a device; (5) even when FDA completes inspections on time, the inspections do not always identify or target GMP violations; (6) FDA recommended and reported compliance action on only about one-half of identified GMP compliance violations; (7) about one-half of the manufacturers that received two or more GMP compliance violations notices did not correct the violations from one inspection to the next; (8) inspectors' investigative capability is limited by FDA assignment policies and inadequate training on device technology; and (9) information on both medical device manufacturers and their devices is unreliable and incomplete.

Full Report