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.