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Highlights

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA): (1) Good Manufacturing Practices (GMP) compliance program, established to define and enforce quality assurance in medical device manufacturing; and (2) inspections and compliance actions.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. The Commissioner, FDA, should evaluate the adequacy of its inspection force in light of the increasing competence and experience in device technology needed to conduct device inspections and develop a comprehensive plan to provide adequate technical resources.
Closed - Implemented
A significant increase in compliance and enforcement action occurred during fiscal year 1993.
Food and Drug Administration 2. The Commissioner, FDA, should meet the statutory obligation for inspecting manufacturers of medium- and high-risk devices.
Closed - Implemented
A two-track inspection strategy was designed to target chronic non-compliance firms.
Food and Drug Administration 3. The Commissioner, FDA, should expand the current pilot program for premarket GMP review of sterile cardiovascular devices to include all high-risk devices.
Closed - Implemented
FDA and Congress are jointly developing a plan to conduct expanded GMP premarket reviews.
Food and Drug Administration 4. The Commissioner, FDA, should complete the development and deployment of the new Field Information System in order to achieve comprehensive district reporting of inspection results and compliance actions.
Closed - Not Implemented
Congressional and agency priorities dictate a different resource allocation scheme.
Food and Drug Administration 5. The Commissioner, FDA, should upgrade documentation of the inventory of device manufacturers subject to GMP inspections and develop an inventory of medical devices to serve as benchmarks to assess GMP program effectiveness and the rate of device defects over time.
Closed - Implemented
Draft legislation related to user fees for device manufacturers expedited action on this recommendation in fiscal years 1994-1995.
Food and Drug Administration 6. The Commissioner, FDA, should assess the impact of proposed new GMP regulations, by monitoring the inspection process and the rate of device defects before and after implementation.
Closed - Not Implemented
Regulation has been delayed to some indeterminate time by shift in agency and congressional priorities.

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