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

FDA and industry action on Premarket Approval Application (PMAs): Effect on FDA review Clock and Goals. 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.

Performance goals were negotiated and agreed to under MDUFA V for PMAs received in FY 2023-2027. These performance goals and process improvements are outlined in the letter from the Secretary of Health and Human Services to Congress (MDUFA V Commitment Letter) and are further described in this guidance document.