Trade Law Daily is a Warren News publication.

FDA Posts New Draft Guidance on Device Reporting and Recordkeeping

A new draft guidance is now available on Medical Device Reporting (MDR) adverse event reporting and recordkeeping regulations for manufacturers, said the Food and Drug Administration. Once finalized, the guidance will update FDA policy and clarify the agency’s interpretation of…

Sign up for a free preview to unlock the rest of this article

Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.

the MDR regulations, it said. The guidance will be available on FDA’s website (here).