During the review of a premarket submission, the review clock is impacted by both FDA’s and industry’s action. The Medical Device User Fee Amendments of 2017 (MDUFA IV), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2017, including premarket notification submissions (510(k)s). 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.

Medical device user fees were initially authorized by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).3 Since MDUFMA was first enacted in 2002, it has been reauthorized three times (the Medical Device User Fee Amendments of 2007 (MDUFA II), the Medical Device User Fee Amendments of 2012 (MDUFA III), and the Medical Device User Fee Amendments of 2017 (MDUFA IV)). For additional information on medical device user fees, please see https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/default.htm.

The purpose of this guidance document is to identify: (1) the types of 510(k)s 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 incorporates the impact of process improvements from MDUFA IV.