Industry Says MDR Draft Guidance Would Lead To Redundant Reporting-thegraysheet: FDA proposed changes to the MDR system in a draft guidance (PDF) released in July. The draft explains FDA’s regulations for manufacturer adverse event reporting and recordkeeping, and clarifies FDA’s interpretations of the requirements. The guidance also features a new “frequently asked questions” section and a list of common errors made by devices companies in their adverse event reports. Once finalized, it will replace FDA’s 1988 and 1997 MDR guidances.
