User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications Guidance for Industry and Food and Drug Administration Staff October 2022
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The Medical Device User Fee Amendments of 2022 (MDUFA V), amended the Federal Food, Drug, and Cosmetic Act (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) and certain biologics license applications (BLAs). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the medical device review process to meet certain performance goals and implement improvements for the medical device review process as outlined in the letter from the Secretary of Health and Human Services to Congress.
The purpose of this guidance document is to identify: (1) the types of PMAs and BLAs subject to device user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user fees that have been paid.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2009-D-0051.