During the review of a premarket submission, the review clock is impacted by both FDA's and Industry's actions. The Medical Device User Fee Amendments of 2017 (MDUFA IV), 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, 2017, 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 IV process improvements.