A federal watchdog report highlights audit delays exceeding six months for accredited organizations handling 510(k) reviews for low-to-moderate risk devices.
The Food and Drug Administration (FDA) should strengthen its policies for auditing organizations participating in its Third Party Review Program, according to a report from the US Government Accountability Office (GAO).
The federal watchdog found that FDA lacks target time frames for completing audits of third-party review organizations and communicating findings. Some recent audits that identified deficiencies took more than six months to close, according to the report.
The Third Party Review Program, authorized under the Food and Drug Administration Modernization Act of 1997 and administered by the Center for Devices and Radiological Health (CDRH), allows device sponsors to contract with accredited outside organizations to conduct initial premarket 510(k) reviews for eligible low-to-moderate risk devices, including surgical lasers and diagnostic ultrasound systems. FDA staff review the third parties’ recommendations before making final clearance decisions.
According to the GAO, approximately $8 million was carried over to support the program’s operations across fiscal years 2023 through 2027. Although the program provides an alternative pathway for 510(k) reviews, third parties completed 617 reviews between fiscal years 2018 and 2025, accounting for about 2% of CDRH’s annual 510(k) reviews.
Audit Gaps and Resolution Delays
Under the program, FDA conducts periodic audits of third parties to determine whether they continue to meet accreditation requirements. Agency records show that FDA conducted 25 periodic audits between 2000 and 2026: 13 between 2000 and 2003, five between 2011 and 2013, two in 2022, and five between 2025 and 2026.
The GAO found gaps in FDA’s policies for conducting those audits. Specifically, the agency has not established target time frames for completing audits or communicating findings to participating organizations.
Some recent audits that identified deficiencies—including vague language in one organization’s standard operating procedures—took FDA more than six months to close, according to the report.
Participation in the program has also narrowed over time. FDA has accredited 32 third parties since the program began, but only nine held active accreditations as of May 2026, according to the GAO.
GAO Recommendations
The GAO recommended that the FDA commissioner update policies governing audits under the Third Party Review Program. The updated policies should establish criteria for selecting organizations for audit, reflect current post-audit practices, and set target time frames for completing audits and communicating findings.
The Department of Health and Human Services concurred with the recommendation, according to the report.
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