ARTICLE SUMMARY:
FDA issues premarket review performance data. Excerpted from Pathways' Picks May 17: FDA Performance, Personnel Moves, UK Picks, and More.
The number of original PMAs filed to FDA by device firms dropped off precipitously in 2021 and 2022 during the pandemic, but they appear to be on the upswing. As of the March 31 midway point for fiscal year 2023, 21 PMAs have been filed with FDA, which matches the full year FY 2022 total. But that increased activity is also contributing, at least temporarily, to a growing backlog. As of the end of FY 2022, FDA recorded 47 pending PMAs, but that number has jumped to 67 as of March 31, according to the latest MDUFA premarket performance data posted and presented to industry stakeholders May 10.
Meanwhile, PMA turnaround times are trending slower, the data suggests—for PMA and panel-track supplements submitted in FY 2022, total decision times (including FDA review and manufacturer response) are averaging 239 days with about 63% of the cohort complete at the end of March, compared to a range between 210 and 213 days at the same percentage point of completion in 2017-2020.
510(k) trends positive. Meanwhile, 510(k) decision times appear to be improving—with more than 80% of the FY 2022 receipt cohort complete at the end of March, total decision times were averaging 127 days, a seven-day drop from the like-for-like 2021 performance. That also falls within the 128-day goal FDA agreed to for FY 2023 submissions under the MDUFA V user fee agreement. In addition, the backlog of pending 510(k)s fell by more than 200 applications (from 1,860 to 1,605) from last October to the end of March, according to FDA’s recently posted data. Unlike original PMAs, the volume of 510(k)s coming in FDA’s door did not drop in FY 2021 and 2022, and, if anything, increased a bit.
De Novo slowdown. Device company submissions for De Novo marketing authorizations have continued to come in at a relatively consistent pace through the pandemic, though review times have clearly suffered. With more than 98% of reviews completed for the FY 2020 De Novo cohort as of March 31, the average total decision time has jumped by more than 100 days from the prior year—from 261 to 374—and the times for FY 2021 submissions appear similar with 85% of those reviews complete.