Monday, 2026-09-21 · · run 20260922T0417Z
FDA audit policies have gaps, GAO says
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The Food and Drug Administration should strengthen policies guiding its audits of third-party medical device reviewers, the Government Accountability Office said.
FDA’s audit policies have gaps and are missing key details, the GAO found.
For example, FDA has not established time frames specifying how long it should take the agency to complete an audit and communicate results to third parties.
As a result, GAO identified several recent audits with findings of deficiencies that took FDA more than 6 months to close.
FDA is required to audit third parties periodically to ensure they remain in compliance with the standards for program participation.
The agency conducted 25 periodic audits of third parties from 2000 to 2026, according to FDA officials.
Third parties provided FDA with 617 510(k) submission reviews and recommendations from fiscal years 2018 through 2025.
These accounted for about 2 percent of CDRH’s 510(k) submission reviews annually.
Sources
- Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations Government Accountability Office
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