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.
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 the first quarter of fiscal year 2023 and the second quarter of fiscal year 2026 (October 1, 2022, through March 31, 2026).
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 extended evaluation period, the FDA accepted 255 submissions from FDA-accredited third parties, with 212 (83%) ultimately receiving final decisions from the FDA. An additional 21 submissions to the FDA were withdrawn by the device manufacturer for unspecified reasons.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 submissions ranged from 17 to 41 days over the span of the data reported. Average total time to decision (TTD), measuring the average time from the FDA’s receipt of a submission to a final decision by the agency, ranged from a low of 106 calendar days to a high of 158 days, with a maximum TTD of 743 days.
Read the complete text of the FDA’s latest Performance Report on its Accredited Persons Program.
