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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 Software as a...

Overview of Device Regulation | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    Manufacturers must list their devices with the FDA. Establishments required to list their devices include: manufacturers, contract manufacturers, contract sterilizers, …

Recent Final Medical Device Guidance Documents | FDA

    https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
    Jan 12, 2023

An Introduction to FDA’s Regulation of Medical Devices

    https://www.fda.gov/media/123602/download
    FDA Regulation of Medical Devices FDA’s Role Oldest comprehensive consumer protection government agency Promote and protect health Covers foods, drugs, …

Code of Federal Regulations (CFR) | FDA - U.S. Food …

    https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr
    Code of Federal Regulations (CFR) | FDA Code of Federal Regulations (CFR) FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is …

Devices Guidances | FDA - U.S. Food and Drug …

    https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances
    FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; …

Search for FDA Guidance Documents | FDA - U.S. Food …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents
    The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results …

Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801
    § 801.30 - General exceptions from the requirement for the label of a device to bear a unique device identifier. § 801.35 - Voluntary labeling of a device with a unique …

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

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



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