Medical Device User Fee Amendments; Public Meeting; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing a hybrid public meeting titled "Medical Device User Fee Amendments." The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2028 through 2032. MDUFA authorizes FDA to collect fees and use them for the process for the review of device applications. The current legislative authority for MDUFA expires September 30, 2027. At that time, new legislation will be required for FDA to continue collecting device user fees in future fiscal years. Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.

Tags

health IT, Notice, Health and Human Services Department, Food and Drug Administration

Related exam domains

CISSP 3: Security Architecture and Engineering; CISM 3: Information Security Program

Source record id

2026-13778

First seen by InfoSec Signals

9/23/2026

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