FDA Updates 510(k) Third-Party Performance Metrics

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 October 1, 2017, and December 31, 2021.

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 51-month evaluation period, the FDA accepted 347 submissions from FDA-accredited third parties, with 297 (86%) ultimately receiving final decisions from the FDA, and with 20 decisions pending by the conclusion of the evaluation period. An additional 30 submissions to the FDA were withdrawn by the device manufacturer for unspecified reasons.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 32 calendar days or less, with an average of just 26 days in FY 2022 to date. Average review times in the lowest 25th percentile of submissions were as low as 21 calendar days, while the maximum review time reached as long as 162 days.

Read the FDA’s latest Performance Report on its Accredited Persons Program.

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