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Contact Us

Report Problems With Medical Devices

FDA learns about problems with medical devices through two different systems: Medical Device Reporting (MDR) and MedWatch.

Medical Device Reporting (MDR)

  • Applies to manufacturers, importers, and user facilities
  • Requires reporting of all significant medical device adverse events

    Go to MDR Website Now

MedWatch

  • Applies to consumers and healthcare professionals
  • Accepts voluntary reports of significant adverse events or problems with medical products

    Go to MedWatch Website Now

Contact the Human Factors Team

To reach any member of the Human Factors Engineering Team, you can E-mail us at the address below or write to:

Human Factors Engineering Team
Center for Devices and Radiological Health
Office of Device Evaluation
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID)
9200 Corporate Boulevard, HFZ – 480
Rockville, MD 20850

Phone: (240) 276-3823
FAX: (240) 276-3789

Ron Kaye, Team Leader ron.kaye@fda.hhs.gov
Mike Mendelson michael.mendelson@fda.hhs.gov
Quynh Nhu Nguyen quynht.nguyen@fda.hhs.gov

Updated October 23, 2008

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