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Electronic Medical Device Reporting (eMDR) | FDA

    https://www.fda.gov/industry/fda-esubmitter/electronic-medical-device-reporting-emdr
    The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports. The project utilizes Health...

Medical Device Reporting (MDR): How to Report Medical …

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and …

eMDR – Electronic Medical Device Reporting | FDA

    https://cacmap.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/emdr-electronic-medical-device-reporting
    Electronic Medical Device Reporting (eMDR) On Feb. 13, 2014, the FDA published a final rule on Electronic Medical Device Reporting (eMDR) that requires manufacturers and …

How to Enroll in eMDR Program | FDA

    https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdr-program
    How to Enroll in eMDR Program | FDA How to Enroll in eMDR Program As of August 14, 2015, the FDA published a Final Rule: Medical Device Reporting; …

eMDR System Enhancements | FDA

    https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/emdr-system-enhancements
    Aug 30, 2022

Medical Device Reporting (MDR): How to Report Medical …

    https://cacmap.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and …

FDA Electronic Submissions Gateway (ESG) | FDA

    https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/fda-electronic-submissions-gateway-esg
    The electronic submission process through the ESG encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving FDA …

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
    If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, …

CFR - Code of Federal Regulations Title 21 - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803
    § 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? § …



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