Posted 11 March 2015
By Stewart Eisenhart, Emergo
Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
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.
The final rule also specifies FDA Form 3500A as the required form on which to provide adverse event reports to the agency.
Given the challenges involved with UDI compliance in the US, FDA moves to mitigate any redundancies between UDI and eMDR should at least help eliminate any unnecessary headaches for affected companies.
Original Post at Emergo
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