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Plenary

Medical Device User Fee Amendments (MDUFA) Update

Wednesday, April 22, 2026
10:40 AM - 11:40 AM East Coast USA Time
Location: Regency Ballroom - 3rd Floor

    Moderator(s)

  • Bill Brodbeck

    Vice President, Regulatory Affairs
    STERIS Corporation

  • Heather Rosecrans

    Executive Vice President, Medical Devices & Combination Products
    MDMA & ELIQUENT Life Sciences

    • Speaker(s)

  • Mark Leahey

    President & CEO
    Medical Device Manufacturers Association (MDMA)

  • Barb Marsden

    Acting Office Director, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA (Virtual)

    View Slides
The session will highlight recent findings for MDUFA V (Fiscal Years 2022-2027) and some background on the MDUFA VI negotiations and how they may impact your US regulatory strategies. Hear both Industry Advocacy and FDA leaders describe the process and the outcomes.