GAO Audit Report Shows How FDA's Third-Party 510(k) Review Program Works

The Government Accountability Office said on Sept. 21 that the Food and Drug Administration's policies for auditing the private organizations that review some medical device submissions are "missing some key details," in a report titled "Medical Devices: FDA Should Strengthen Policies Guiding Audits of Third Party Review Organizations" (GAO-26-108499). GAO said FDA has not set time frames for completing an audit and communicating results, and that several recent audits with findings of deficiencies took the agency more than six months to close.

GAO made one recommendation: that the FDA commissioner update the audit policies to include existing criteria for selecting third parties for audits, reflect current post-audit practices, and set target time frames for completing audits and communicating findings. HHS concurred, according to the report.

The program at the center of the report is a little-known side door to the most common route to market for medical devices.

How a third-party review works

Most moderate-risk devices reach the US market through a 510(k), in which a company shows its device is substantially equivalent to one already legally sold. Normally FDA's Center for Devices and Radiological Health (CDRH) reviews the submission. Under the 510(k) Third Party Review Program, formally called the Accredited Persons Program, a company with an eligible device can instead send its 510(k) first to an FDA-accredited review organization.

FDA says use of the program is voluntary and that approximately half of the 510(k)s it receives are eligible. The company pays the review organization, and FDA says that payment is "the sole payment under the program," with no separate user fee to the agency. The organizations use the same criteria FDA uses, may interact with FDA early in the review and may ask the company for more information.

When its review is done, the organization sends FDA the submission and its recommendation. The decision stays with the agency. FDA says it "makes the final determination" based on the review and recommendation, and its goal is a decision within 30 days of receiving the recommendation. If the organization did not apply the 510(k) criteria appropriately, or its documentation has substantive quality problems, FDA says it may need to re-review all or part of the submission, though the agency says it is updating the program to avoid routine re-review.

FDA says the program is intended to yield faster 510(k) decisions and let the agency focus its resources on higher-risk devices. GAO described the eligible devices as selected low-to-moderate-risk products, such as diagnostic ultrasound systems and surgical lasers.

How big the program is

Congress created the program in the Food and Drug Administration Modernization Act of 1997, and the Consolidated Appropriations Act, 2023, directed GAO to report on it. According to GAO, FDA has accredited 32 third parties since the program began, and nine had active accreditations as of May 2026.

GAO's analysis of FDA data found 617 510(k) reviews and recommendations from third parties in fiscal years 2018 through 2025, about 2 percent of CDRH's 510(k) reviews each year. In fiscal 2025, the report's table shows 67 submissions reviewed by third parties and CDRH, against 3,476 reviewed by CDRH alone. FDA officials told GAO the agency received approximately $8 million for program operations in fiscal 2023 through 2027.

Where the audits come in

FDA is required to audit third parties periodically to make sure they still meet the standards for taking part. According to FDA officials quoted by GAO, the agency conducted 25 such audits from 2000 to 2026, in four phases: 13 from 2000 through 2003, five from 2011 through 2013, two in 2022 and five from 2025 to 2026.

GAO said clearer policies would strengthen FDA's efforts to ensure third parties remain eligible to keep reviewing 510(k) submissions. The recommendation is listed as open on GAO's site, pending confirmation of FDA's actions.