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Device Labeling | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
    Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws...

Unique Device Identification System (UDI System) | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
    The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

UDI Basics | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
    Device labelers are required to submit information to the FDA-administered Global Unique Device Identification Database (GUDID). GUDID includes a standard set of basic identifying elements...

Medical Device Tracking | FDA

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
    The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial …

Bar Code Label Requirements | FDA

    https://www.fda.gov/vaccines-blood-biologics/labeling-cber-regulated-products/bar-code-label-requirements
    Blood and blood components must be labeled with with specific machine-readable bar code information by April 26th, 2006. The unit of blood or blood component label would contain …

Guidance for Industry - Food and Drug Administration

    https://www.fda.gov/media/81277/download
    FDA regulations require that certain human drug and biological product labels contain a bar code consisting of, at a minimum, the National Drug Code (NDC) number (21 CFR …

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 …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.25
    Manufacturers, repackers, relabelers, and private label distributors of a human prescription drug product or an over-the-counter (OTC) drug product that is …

2023 Device Approvals | FDA

    https://cacmap.fda.gov/medical-devices/recently-approved-devices/2023-device-approvals
    2023 Device Approvals. The products listed in this section include some of the newest medical technology from the year 2023. The products in each list contain …



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