Current category: Product
FDA Issues Draft e-MDR Guidance - Possibly Goes Mandatory Feb 2011
Rockville, MD. The FDA issued the long awaited guidance for submission of electronic Medical Device Reports (eMDRs) to replace the current mail in method was issued earlier today. The draft seven page guidance is applicable to both industry as well as user facilities.
The guidance addresses the contents and methods of submitting and updating the eMDRs. Comments and suggestions regarding the guidance will be accepted for the next 90 days to www.regulations.gov. The guidance addresses "low volume" and higher volume eMDR submitters. Low volume submitters will be able to submit via free FDA software called CeSub. High volume submitters are directed "to develop an application using the Health Level Seven (HL7) ICSR to create an electronic MDR submission directly from adverse event information in the reporter’s computer system." For a free pdf copy, send an email to info@ requesting it. Alternatively, you may get a copy at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm
For more information on adapting your existing SOP to address eMDR, and which commercially available complaint/CAPA/reporting software is expected to be compatible with eMDR, contact us at info@.