FDA Misses Its Third-Party Review Time Goal

The total time to get an FDA decision on a 510(k) application submitted through a third-party reviewer improved from 2018 to 2022, the FDA reported, but still missed the agency’s goal of a decision in 108 days.

Under the Medical Device User Fee Amendments (MDUFA IV), the FDA had set a goal for 510(k) reviews to be completed in 124 days in 2018, dropping steadily down to 108 days by 2022.

The average total review time declined from 170 calendar days in 2018 to 126 in 2022, but there was a pandemic-related spike to 190 days in 2020, according to the agency’s report on its third-party performance for the final quarter of fiscal 2022.