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.
Recommendations for Executive Action
|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.|
|Food and Drug Administration||2. The Commissioner, FDA, should meet the statutory obligation for inspecting manufacturers of medium- and high-risk devices.|
|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.|
|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.|
|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.|
|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.|