On November 8, 2016, FDA issued final guidance to describe and explain FDA’s current regulation that addresses reporting and record keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.
These requirements are contained in the Medical Device Reporting (MDR) regulation in 21 CFR Part 803.
This guidance also updates FDA’s policy, clarifies FDA’s interpretations of the regulation requirements, and includes a section on common reporting errors.
This guidance is intended only for medical device manufacturers.
However, certain requirements applicable to user facilities, importers, and distributors are summarized in Appendix A of the guidance.
This final guidance supersedes “Medical Device Reporting for Manufacturers”, dated March 1997.