Tuesday, April 21, 2015

US FDA Amends eMDR Rules to align with Unique Device Identification Program - Posted on RAPS

US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system.

All changes will affect federal regulation 21 CFR Part 803 covering medical device reporting. Among the changes in the FDA final rule are requirements for what manufacturers, user facilities and importers should include in adverse event reports: identifying device number such as model, catalog, serial or lot number; expiration date; and UDI appearing on device label or package.


View full article on RAPS -> US FDA Amends eMDR Rules to align with Unique Device Identification Program