FDA Final Rule Restores UDI Requirements Unintentionally Removed by eMDR Regulations

March 4, 2015 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has issued a final rule amending its regulation regarding postmarket electronic medical device reporting (eMDR) to address the unintentional removal of certain provisions of the Unique Device Identification (UDI) System regulations. In the September 24, 2013, Federal Register, FDA published the Unique Device Identification System final rule (UDI rule), which among other things, amended part 803 of the Code of Federal Regulations (see the September 25, 2013, HRC Alerts).

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