The U.S. Food and Drug Administration (FDA) has published its most recent data on the performance of accredited third parties conducting primary reviews of medical devices under the Agency’s 510(k) process.
Published in late 2022, the FDA’s “Third Party Review Organization Performance Report” summarizes the activity of third parties accredited by the FDA’s Accredited Persons Program who completed at least five 510(k) submissions in each federal fiscal year between October 1, 2017, and September 30, 2022 (a five-year span).
Created under the scope of the FDA Modernization Act of 1997, the FDA’s Accredited Persons Program is intended to improve the efficiency and timeliness of medical device 510(k) reviews and help speed market access for medical devices.
During the 60-month evaluation period, the FDA accepted 406 submissions from FDA-accredited third parties, with 394 (97%) ultimately receiving final decisions from the FDA. An additional 31 submissions to the FDA were withdrawn by the device manufacturer for unspecified reasons.
For those submissions receiving a final FDA decision, the average FDA review time for third-party submission was 34 calendar days or less, with an average of just 26 days in FY 2022. Average review times in the lowest 25th percentile of submissions were as low as 15 calendar days in FY 2022, while the maximum review time reached as long as 184 days in FY 2021.