GAO urges FDA to set audit timeframes for third-party device reviewers

The Government Accountability Office's report GAO-26-108499 finds that the Food and Drug Administration's audit policies for its Third Party Review Program lack key details and recommends that the agency update those policies to include target time frames for completing audits and communicating findings.

The Center for Devices and Radiological Health runs a voluntary program that allows FDA-accredited third-party organizations to review low-to-moderate risk medical devices, such as diagnostic ultrasound systems and surgical lasers. The agency received approximately $8 million for program operations in fiscal years 2023 through 2027. From fiscal years 2018 through 2025, third parties provided 617 510(k) submission reviews, accounting for about 2 percent of CDRH's annual 510(k) reviews.

FDA conducted 25 periodic audits of third parties from 2000 to 2026. The audits occurred in four phases: 13 audits from 2000 through 2003, five audits from 2011 through 2013, two audits in 2022, and five audits from 2025 to 2026. GAO identified recent audits with deficiencies - such as vague language in standard operating procedures - that took the agency more than six months to close because no audit-completion timeframes were established.

GAO's sole recommendation is that the FDA Commissioner update the agency's audit policies to incorporate existing selection criteria, reflect current post-audit practices, and set target time frames for audit completion and result communication. The Department of Health and Human Services has concurred with the recommendation, which remains open pending FDA action.