tylko submisje w 510k mogą być dotknięte jakimś opóźnieniem, te w toku są normalnie procedowane:
Specific Impact on the 510(k) Procedure
- What Continues Unaffected: Reviews of pending 510(k) submissions (already filed and paid for with prior user fees) proceed normally using carryover funding. This includes:
- Ongoing evaluations of 510(k) notifications, supplements, and amendments.
Related clinical research requests and guidance tied to user fees. The FDA aims to meet performance goals (e.g., 128 calendar days average for 510(k) decisions in FY 2023 targets, with similar expectations here).