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Plenary

FDA OMDRHI Overview (Office of Medical Device & Radiological Health Inspectorate

FDA Medical Device Inspections

Wednesday, April 23, 2025
10:30 AM – 11:05 AM East Coast USA Time
Hear an overview from FDA’s OMDRHI, the new Office of Medical Device and Radiological Health Inspectorate (OMDRHI) under the new OII. This will include focus areas of the new structure as well as status of ongoing inspectorate mission and pending QMSR implementation.

    Moderator(s)

  • Phil Pontikos

    Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)
    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)

  • 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)