Pathways' Pick of the Week: FDA Performance Holds Steady

There were no obvious signs of a drastic shift in medical device review performance at FDA in data recently reported to stakeholders reflecting activity through March 31. The agency met with industry groups May 30 to present performance measured against MDUFA V user fee goals through the second quarter of FY 2025. FDA posted the data tables from that meeting publicly last week. The report period encompassed workforce disruptions at CDRH, including an upsurge in employees taking retirement/resignation incentives and firings (reversed in many cases) of probationary employees, though it predates the large-scale HHS “reduction in force” carried out on April 1. There are some possible signs of softening in review performance, but it is too early to distinguish between typical variations from specific impacts from resource restraints. A few key data points:

• For original PMAs and panel-track supplements (PMA/PTS), volume-adjusted average total decision times are trending slightly longer with more applications pending. As of March, decisions on PMA/PTS submitted in FY 2024 took an average of 240 days, with 55% of the application reviews completed, compared to the same time last year, when FY 2023 submissions averaged 230 days, with 68% of the cohort completed.
• A total of 94 PMA/PTS decisions were still pending at the end of Q2, compared to 64 at the same time last year.
• 510(k) average decision times and the number of pending 510(k)s remained relatively flat compared to the same time last year
• De Novo decision times showed improvements—229 days on average for the FY 2024 cohort, compared to 255 days for the FY 2023 cohort at the same time last year
• There were no signs in degradation in FDA responding to Pre-Submissions requests through March.

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