This draft guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.1 These requirements are contained in our Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). References to FDA regulations and Federal Register documents, as well as cross-references within this guidance document, are hyperlinked for your convenience.
This guidance document is being distributed for comment purposes only.