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Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Classify Your Medical Device 1. Class I General Controls With Exemptions Without Exemptions 2. Class II General Controls and Special Controls With Exemptions Without Exemptions 3. Class III General Controls and Premarket Approval

Overview of Medical Device Classification and …

    https://www.fda.gov/about-fda/cdrh-transparency/overview-medical-device-classification-and-reclassification
    The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of...

Device Classification Panels | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels
    FDA has classified and described over 1,700 distinct types of devices and …

Training and Continuing Education | FDA

    https://www.fda.gov/training-and-continuing-education
    FDA Learning Portal for Students, Academia, and Industry Find education and resources related to FDA’s regulatory, product quality, and safety responsibilities. Learn More …



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