FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff

Issue Date: October 3, 2022
Issued by: Center for Biologics Evaluation and Research
Topic(s): Premarket, Administrative / Procedural
Status: Final

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration 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 De Novo classification requests (De Novo requests). 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 De Novo requests received in FY 2023-2027. These performance goals are outlined in the MDUFA V Commitment Letter from the Secretary of Health and Human Services (the Secretary) to Congress and are further described in this guidance document.

Download the Guidance Document