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FDA's New MDR Regulations:What Manufacturers Need to Know

Edward M. Basile and Elizabeth A. Schmidtlein



FDA's new MDR regulations require device user facilities to report device-related deaths and serious injuries to the agency. User facilities include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, and outpatient treatment facilities, but not physicians' offices. Device user facilities must report the following:

  • Device-related deaths to FDA and to the manufacturer.
  • Device-related serious injuries to manufacturers, or, if the manufacturer is unknown, to FDA.

User facilities are not required to file MDR reports for device malfunctions.

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