GAO published report 26-108499 on September 21 and found FDA has never audited four of the nine organizations accredited to review 510(k) submissions on its behalf. FDA has completed 25 periodic audits of the program since 2000. It has set no time frame for how long finishing one should take.
The program is small and shrinking. Third parties handled 617 submissions between fiscal 2018 and fiscal 2025, about 2 percent of 510(k)s a year, and volume fell from 90 reviews in fiscal 2021 to 67 in fiscal 2025. FDA has accredited 32 organizations since 1998 and nine are active. Recent audits that turned up deficiencies took the agency more than six months to resolve, so an organization can keep taking submissions while out of compliance.
GAO made one recommendation: write down the audit selection criteria, update post-audit policy to match what staff actually do, and set target time frames. HHS concurred and the recommendation is open. One FDA official runs most of the program, which GAO flagged as a knowledge retention risk.
For a startup deciding between FDA and an accredited third party on an eligible device, the draw was always the review clock. Nothing here changes that calculation. It does put a number on how thinly the program is watched, which is worth knowing before you hand a submission to a reviewer nobody has checked in eight years.