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Review of the Food and Drug Administration's Processes to Review Medical Device Submissions Under the Pre-Market Approval and Investigational Device Exemption Programs

Issued on  | Posted on  | Report number: A-15-95-50001

Report Materials

EXECUTIVE SUMMARY:

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.

Report Type
Audit
HHS Agencies
Food and Drug Administration
Issue Areas
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Target Groups
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Financial Groups
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Notice

This report may be subject to section 5274 of the National Defense Authorization Act Fiscal Year 2023, 117 Pub. L. 263.