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 during the first six months of fiscal year 2023 (October 1, 2022, through March 31, 2023).
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 6-month evaluation period, the FDA accepted 35 submissions from FDA-accredited third parties, with 24 (69%) ultimately receiving final decisions from the FDA, with 11 decisions pending by the conclusion of the evaluation period. Unlike prior review periods, none of the submissions made during the review period were withdrawn by the device manufacturer for unspecified reasons.
For those submissions receiving a final FDA decision, 96% were achieved within 30 calendar days, with an average FDA total review time of just 23 days. Average review times in the lowest 25th percentile of submissions were as low as 19 calendar days, while the maximum review time reached as long as 70 days.