The FDA's review process for medical devices can be both time-consuming and expensive. FDA's Third Party Review Program is a voluntary, alternate review process that uses 3rd-party organizations to review certain low-to-moderate risk medical devices, such as surgical lasers.
But the U.S. Government Accountability Office is urging the FDA to audit these organizations to ensure they comply with program standards, adding that the agency's audit policies are missing some key details. For example, the agency hasn't established time frames for completing an audit and communicating the results to these organizations.
According to FDA officials, the agency received approximately $8 million for Third Party Review Program operations in fiscal years 2023 through 2027. FDA’s administration of the program includes overseeing third parties’ accreditation and reaccreditation applications to ensure participation standards are met, and reviewing third parties’ recommendations on 510(k) submissions and making final decisions. From fiscal years 2018 through 2025, third parties provided FDA with 617 510(k) submission reviews and recommendations, which accounted for about 2 percent of CDRH’s 510(k) submission reviews annually.
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. These audits were conducted 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. Results of these audits varied in terms of the deficiencies identified.
GAO found that FDA’s audit policies have gaps and are missing key details. 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, such as language in standard operating procedures being too vague, that took FDA more than 6 months to close. Ensuring the agency has detailed policies, such as time frames for completing audits and communicating results, would strengthen FDA’s efforts to ensure third parties meet program requirements and are therefore eligible to continue reviewing 510(k) submissions, which provide recommendations to FDA as to whether devices should be allowed on the market and thus available for patient use.
The GAO is making one recommendation to FDA to update its policies for the Third Party Review Program audit process to include, for example, target time frames for completing audits and communicating findings to third parties. HHS concurred with GAO’s recommendation.
