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Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: [email protected]. For assistance with policy or ...

Device Registration and Listing | FDA

    https://cacmap.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    Knowing where devices are made increases the nation's ability to prepare for and respond to public health emergencies. For assistance with registration and listing …

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 …

Establishment Registration & Device Listing - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
    This database includes: medical device manufacturers registered with FDA and. medical devices listed with FDA. Note: Registration of a device establishment, …

Device Registration and Listing Module (DRLM): Step-by …

    https://www.access.fda.gov/drlm/help/index.html
    Change, Deactivate, or Reactivate Listings: Modify your active medical device listings: Add or delete proprietary names. Associate other registrations with a listing number. Remove a registrations' association …

Establishment Registration & Device Listing - Food and …

    https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?xss=1
    Databases. This database includes: medical device manufacturers registered with FDA and. medical devices listed with FDA. Note: Registration of a …



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