What Happened?

Patients could get devices reviewed by medical groups working outside the rules for months, as gaps let those reviews continue during long audits. The Food and Drug Administration (FDA), the agency that decides which medical products can be sold in the U.S., has no target deadlines for finishing audits or sharing findings, according to an audit report published Sept. 21.

The program at issue is the Third Party Review Program, a voluntary path where makers pay an FDA-accredited outside group for the first review before FDA officials make the final call. Those applications are called 510(k) submissions, the paperwork for selected low to moderate risk products.

Since the program started, FDA has accredited 32 outside groups, and nine held active accreditations as of May. From fiscal years 2018 through 2025, outside groups gave FDA 617 reviews, about 2 percent of annual reviews by the Center for Devices and Radiological Health (CDRH), the FDA center that runs the program.

The program received $14 million for fiscal years 2018 through 2022 and spent about $6 million during that period. The remaining $8 million was carried over for operations in fiscal years 2023 through 2027.

Why Does it Matter to Me?

Third-party reviews provide recommendations to FDA about whether devices should be allowed on the market for patient use. The devices in this path are selected low-to-moderate risk products, including diagnostic ultrasound systems and surgical lasers.

When audits drag on, a group not following standards can keep reviewing new devices. In one case after a 2022 audit, FDA took five months to tell the group what to fix, including a rule meant to stop the same specialist from doing both the first and final check. Some recent audits with problems took six months or longer, and two of three audits done in 2025 were not closed until June while another was still open.

Both Sides, Now

The U.S. Government Accountability Office (GAO), the nonpartisan research arm of Congress, found FDA audit policies do not list the criteria officials use to pick groups, contain outdated steps after an audit, and set no target time frames. Without those details, FDA risks letting reviewers keep handling applications while not meeting standards.

FDA officials told the report writers that auditing groups with no reviews would not give useful information, which applied to two groups accredited in 2017 and 2020 that had done no reviews as of June. The Department of Health and Human Services (HHS), the parent agency of FDA, agreed to fix the policies and said it would give staff clear guidance on picking groups and clarify procedures and time frames.

Congress ordered this review in the Consolidated Appropriations Act of 2023, and the report was prepared for the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee. The report recommends the FDA commissioner update audit policies to add selection criteria, reflect current follow-up practices, and set target time frames.

What Happens Next?

FDA still needs to update its audit policies, and the recommendation remains open. Until it does, the agency risks letting outside groups review applications while not meeting standards as it finalizes findings.

FDA guidance issued in 2024 defines periodic audits as occurring at least once every three years, and two groups accredited in 2026 must be audited within three years under that guidance. The Department of Health and Human Services said it would update its policies, and the recommendation remains open.

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