eMDR Updates Target Usability, Data Consistency Improvements

April 6, 2016 | Strategic Insights for Health System


​The U.S. Food and Drug Administration (FDA) has announced several updates to its Electronic Medical Device Reporting (eMDR) system. Manufacturers and importers must now submit reports electronically; the system is available to device user facilities, but they can also continue to submit written reports to the agency. Changes include a new field for manufacturers to enter unique device identifier (UDI) information, if known; a new requirement for inclusion of both a device problem code and a patient problem code; and the ability to allow both old and new information in supplemental reports.

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