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Plenary

FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH

Wednesday, April 23, 2025
11:10 AM – 11:40 AM East Coast USA Time
FDA restructured its field operations (formerly the Office of Regulatory Affairs and now the Office of Inspections and Investigations, or OII) on October 1, 2024. FDA restructured and renamed the field operations unit to focus on inspections, investigations, and imports as its core mission. This also included compliance staff and functions moving to CDRH. Come hear from a panel of OII and CDRH experts on how these changes impact the Medical Device industry.

    Moderator(s)

  • Gina Brackett

    Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA (Invited)

  • 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)

    • Speaker(s)

  • 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)

  • Commander Cesar Perez

    Director, Division of Establishment Support, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA (Invited)

  • 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)