Draft Guidance Tackles Common Errors In Adverse Event Reporting-thegraysheet: FDA issued a revised guidance (PDF) on its medical device reporting requirements for manufacturers, including a new “frequently asked questions” section and a list of common errors made by device companies in their adverse event reports to FDA. The draft guidance, which will replace FDA’s 1988 and 1997 MDR guidances once finalized, explains FDA’s regulations for manufacturer adverse event reporting and recordkeeping and clarifies the agency’s interpretations of the requirements.
