FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals

3 October 2022 — FDA published the final PMA guidance on effect on FDA review clock and goals under MDUFA for industry and FDA staff.

The Medical Device User Fee Amendments of 2022 (MDUFA V) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2022, including premarket approval applications (PMAs). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.