FDA Releases Draft Commitments Letter for Medical Devices Review, Public Meeting Scheduled

The U.S. Food and Drug Administration (FDA) published a notice in the Federal Register on July 7, 2026, announcing the availability of the draft commitments letter for the Medical Device User Fee Act (MDUFA) reauthorization. The draft commitments letter outlines policies and procedures for medical devices at all stages as agreed upon by the FDA and medical device industry, which have met regularly for more than a year. The public meeting on the draft commitments letter will take place on August... By: Holland & Knight LLP