USA – FDA rules on definitions of device; issues revised form for reporting adverse events

The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends to reference the definitions of “device” and “counterfeit device” in guidances, regulatory documents and other communications and documents for FDA staff, industry and other stakeholders going forward.

In addition, the FDA has revised the MedWatch Form 3500A used by importers, distributors, manufacturers and user facilities in the mandatory reporting of adverse events associated with the use of medical products, including medical devices…