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Who Must Register, List and Pay the Fee | FDA

    https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
    Who Must Register, List and Pay the Fee | FDA Who Must Register, List and Pay the Fee Establishments that are involved in the production and distribution of medical devices intended for...

Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …

Importing Medical Devices | FDA

    https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
    Registration and listing. Establishments that are involved in the production and distribution of …

Medical Device Databases | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    Apr 6, 2022

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1&subpartNode=21:8.0.1.1.13.3
    Sec. 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements. (a) A distributor, final distributor, or multiple …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803&showFR=1
    (e) Distributor means any person (other than the manufacturer or importer) who furthers the marketing of a device from the original place of manufacture to the …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=821.3
    (i) Final distributor means any person who distributes a tracked device intended for use by a single patient over the useful life of the device to the patient. This …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=807.3
    (t) Wholesale distributor means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the …

US FDA Medical Device Distributor Regulations - Elsmar Cove …

    https://elsmar.com/elsmarqualityforum/threads/us-fda-medical-device-distributor-regulations.63888/
    As a distributor of medical devices, what regulatory information should we consider collecting and retaining in our side. 2. What are the FDA regulations that a …



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