A draft guidance entitled “Medical Device Reporting for Manufacturers” has been released from the Food and Drug Administration. The draft guidance explains the current FDA regulation addressing reporting and recordkeeping requirements for certain device-related adverse events.
This draft guidance updates FDA’s policy to clarify interpretations of the regulation requirements and will supersede previous manufacturer guidances (1988 and 1997) when finalized. Note, this is a draft guidance and is not currently in effect nor final. Details are available on the Federal Register website.
