FDA needs to improve follow-up, GAO reports
The U.S. Food and Drug Administration (FDA) should be more thorough in following through with problems identified in the medical device reporting (MDR) program. That’s the verdict in a recently published report from the Government Accounting Office (GAO).
The support for the GAO statement comes from claims from manufacturers that the MDR information does not help protect patients or inform providers of other facilities who reported similar problems. The GAO report further states that the FDA does not use the information to identify potential problems with similar devices.
The FDA also does not maintain reliable information on the length of time it takes manufacturers to fix problems identified in the MDR program, the GAO report concludes. Response from the FDA may be improved, however, by the new Manufacturer and User Device Experience database, the GAO report points out. The database was implemented in August 1996.