Issue Date: October 5, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, User Fees, Administrative / Procedural
Status: Final
User Fees and Refunds for De Novo Classification Requests : 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 De Novo classification requests (De Novo requests). The additional funds obtained from user fees enable FDA, with the cooperation of industry, 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 De Novo requests subject to user fees; (2) exceptions to user fees; and (3) the actions that may result in refunds of user fees that have been paid. This document also incorporates MDUFA V process improvements.
Download the Guidance Document
