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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
    Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form ...

Medical Device Reporting for Manufacturers | FDA

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers
    These requirements are contained in our Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), Part 803, as authorized by section 519 of …

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

    https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
    You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Your annual report must include: ( 1) Your CMS …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803
    TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. …

Medical Device Reporting | FDA

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/medical-device-reporting
    Purpose/Importance. The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that …

Overview of Device Regulation | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Mandatory Reporting Requirements: Manufacturers, …

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities
    For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: (301) 796-6670. Email: [email protected]. Or write to: Food and …

Medical Device Reporting Regulation History | FDA

    https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/medical-device-reporting-regulation-history
    The new medical device reporting regulation, published December 11, 1995, no longer defines a manufacturer as a person whom FDA requires to register under 21 CFR Part …

eMDR – Electronic Medical Device Reporting | FDA

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

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820
    The information on this page is current as of Jul 20, 2022. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations …



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