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Plenary

FDA Medical Device Inspections

Wednesday, April 23, 2025
10:05 AM – 10:50 AM East Coast USA Time
Location: Regency Ballroom – 3rd Floor
This virtual plenary session will feature FDA leaders of the Office of Medical Device and Radiological Health Inspectorate (OMDRHI) under the new Office of Inspections and Investigations (OII). Hear about the core mission of Inspections of Medical Device Manufacturers, priorities, the reorganization effective 10/1/2025 that streamlines functions, as well as status of pending QMSR implementation.

    Moderator(s)

  • Susan Matthias

    Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA (Virtual)

  • Phil Pontikos

    Retired, FDA

    • Speaker(s)

  • Anne Reid

    Office Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA (Virtual)

    View Slides

  • Rhonda Mecl

    Deputy Program Director, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA (Virtual)