Medical Technology:

Quality Assurance Needs Stronger Management Emphasis and Higher Priority

PEMD-92-10: Published: Feb 13, 1992. Publicly Released: Mar 26, 1992.

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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.

GAO found that: (1) FDA has changed its interpretation of the original 1978 GMP regulations, shifting to more stringent requirements; (2) the stronger requirements are not self-explanatory and require FDA inspectors to have extensive knowledge of device technology; (3) until 1990, the effectiveness of GMP inspections was limited by a lack of coordination with market introduction, but GMP inspections are now part of the approval process for certain high-risk devices that FDA must approve before marketing; (4) FDA began a pilot premarket review of another group of high-risk devices, which may also result in premature GMP inspection of the device manufacturer, but the pilot review program does not transmit technical data to FDA field offices to help them target inspections to the riskiest technology changes; (5) the shift to more stringent GMP requirements gives FDA inspectors greater authority and responsibility to assess technical dimensions of device specifications and manufacturing processes, but current classroom training and job assignment policies severely limit inspectors' knowledge of device technology and ability to identify quality assurance problems in complex devices and manufacturing; (6) district offices did not report 36 percent of potential GMP violations to central FDA files; (7) the missing data restricted FDA ability to monitor manufacturing problems nationally; (8) FDA has conflicting estimates for the inventory of domestic manufacturers' medium- and high-risk devices, and does not attempt to estimate the inventory of medical devices; (9) the new FDA Field Information System could address district reporting and data system problems; and (10) FDA has not met its minimum statutory obligation to inspect medium- and high-risk device manufacturers at least once every 2 years.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: Draft legislation related to user fees for device manufacturers expedited action on this recommendation in fiscal years 1994-1995.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Not Implemented

    Comments: Congressional and agency priorities dictate a different resource allocation scheme.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Implemented

    Comments: FDA and Congress are jointly developing a plan to conduct expanded GMP premarket reviews.

    Recommendation: The Commissioner, FDA, should expand the current pilot program for premarket GMP review of sterile cardiovascular devices to include all high-risk devices.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Implemented

    Comments: A two-track inspection strategy was designed to target chronic non-compliance firms.

    Recommendation: The Commissioner, FDA, should meet the statutory obligation for inspecting manufacturers of medium- and high-risk devices.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  5. Status: Closed - Implemented

    Comments: A significant increase in compliance and enforcement action occurred during fiscal year 1993.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  6. Status: Closed - Not Implemented

    Comments: Regulation has been delayed to some indeterminate time by shift in agency and congressional priorities.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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