The Food and Drug Administration has released updated timelines for de novo classification requests, premarket approval applications, and premarket notification 510(k) submissions to comply with the review schedule agreed to under the newly ratified Medical Device User Fee Amendments of 2022 (MDUFA V). The following infographic outlines the FDA’s possible pathways after applications are submitted, as well as what timelines device sponsors can expect.
The new timelines were included in FDA guidance documents released on 3 October.