What are FDAs requirements for reporting an adverse event with a SUD reprocessed by the hospital?
Answer. If a hospital reprocesses a device that was previously marketed as a single-use device, FDA considers the hospital to be the manufacturer of that device and subject to the same adverse event reporting requirements (Medical Device Reporting or “MDR”) as original equipment manufacturers or commercial reprocessors. A manufacturer is defined in Title 21 of the Code of Federal Regulations (CFR) at 803.3(o) as “any person who manufactures, prepares, propa-gates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.” The manufacturer MDR requirements are in addition to the hospital’s current user facility adverse event reporting requirements. Information on MDR requirements is available on the Internet.
