Department of Health and Human Services

Office of Inspector General -- AUDIT

"Review of the Food and Drug Administration's Processes to Review Medical Device Submissions Under the Pre-Market Approval and Investigational Device Exemption Programs," (A-15-95-50001)

March 6, 1996

Complete Text of Report is available in PDF format (1.1 mb). Copies can also be obtained by contacting the Office of Public Affairs at 202-619-1343.

This final report provides the results of our review of the Food and Drug Administration's (FDA) Center for Device and Radiological Health's (CDRH) controls for ensuring the integrity of the Pre-Market Approval (PMA) and Investigational Device Exemption (IDE) application review processes. In general, since 1992, CDRH has taken corrective action that should enhance the integrity of these processes. However, we are recommending that CDRH further strengthen the integrity of these decisionmaking processes by fully implementing a program for conducting independent internal quality control reviews. The FDA concurred with our recommendation.