Issue Date: October 5, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, User Fees,
Status: Final
User Fees for 513(g) Requests for Information: 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 (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 requests for information under section 513(g) of the FD&C Act (“513(g) request”). 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 assist FDA staff and regulated industry by describing the user fees associated with 513(g) requests.
Download the Guidance Document
