Devices

Stronger FDA Oversight of Third-Party Device Reviewers Needed: GAO

A new Government Accountability Office (GAO) report has found gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations. The 9/21 GAO report recommends that the agency update its audit policies to establish clearer procedures and target time frames for completing audits and communicating findings.

FDA's Third-Party Review Program allows manufacturers of certain low-to-moderate-risk medical devices, including diagnostic ultrasound systems and surgical lasers, to contract with FDA-accredited organizations to conduct initial reviews of 510(k) submissions. FDA retains responsibility for making final clearance decisions.

The program is intended to accelerate reviews and allow FDA to concentrate its resources on higher-risk devices. However, third-party organizations accounted for only about 2% of CDRH's annual 510(k) reviews between fiscal years 2018 and 2025, submitting a total of 617 reviews and recommendations during that period.

GAO found that FDA conducted 25 periodic audits of third-party review organizations between 2000 and 2026, including five audits during 2025 and 2026. As of May, five of the nine organizations with active accreditations had undergone audits since FDA issued guidance in 2024 requiring audits at least once every three years. Four accredited organizations had never been audited, although two received accreditation in 2026 and the other two had not conducted any 510(k) reviews as of June 2026, the report found.

GAO identified several deficiencies in FDA's audit procedures, including the absence of documented criteria for prioritizing audits and established time frames for completing audits and communicating findings. It said that several recent audits identifying deficiencies took FDA more than six months to close.

GAO also reported that a 2021 audit conducted for cause uncovered falsified reviewer credentials and fraudulent documents submitted to FDA, resulting in the withdrawal of the organization's accreditation.

GAO concluded that more detailed audit policies would strengthen FDA's ability to ensure that third-party organizations continue meeting accreditation requirements and remain qualified to review medical device submissions.

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