Medical device regulators at the 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.

The changes will affect 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.

The final rule also specifies FDA Form 3500A as the required form on which to provide adverse event reports to the agency.

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