FDA Releases 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.

Published in late April, 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 March 31, 2018.

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 30-month evaluation period, the FDA accepted 282 submissions from four different accredited third parties, with 244 (86%) ultimately receiving final decisions from the FDA, and with 22 decisions pending by the conclusion of the evaluation period. An additional 16 submissions to the FDA were withdrawn by the device manufacturer for unspecified reasons.

For those submissions receiving a final FDA decision, average FDA review time for third-party submission was 32 calendar days or less, with an average of just 26 days in FY 2020. Average review times in the lowest 25th percentile of submissions was as low as 22 calendar days, while the maximum review time reached as long as 108 days.

Interestingly, the data suggests that the average review times for FDA decisions regarding third-party submissions may have benefited significantly from the extensive review conducted by third parties prior to their filing a 510(k) submission with the Agency. The average total time for third-party reviews conducted prior to an FDA 510(k) filling during the period ranged from 127 to 154 calendar days, with average review times in the lowest 25th percentile of between 49 and 66 days. However, the maximum total review time was as long as 836 days for submission data collected during FY 2020.

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

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