The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under the latest Medical Device User Fee Amendments (MDUFA V) program.
After Congress renewed FDA’s user fee programs in an eleventh-hour budget deal last month, the agency published several guidances on 3 October updating its committed goals under MDUFA V. For de novo applications submitted between FY 2023 and 2027, regulators said they will try review at least 70 % of submissions within 150 days. (RELATED: Sigh of relief as Congress reauthorizes user fee agreements, Regulatory Focus 30 September 2022)
The latest MDUFA agreement also includes additional funding from industry if FDA can hit certain goals. With that in mind, the agency notes that if they can review 70% of de novo applications in FY 2023, they will then aim to review 80% of de novo applications in FY 2026. Similarly, if they can review 80% of de novo applications in FY 2024, they will try to review 90% of them in FY 2027…
