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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, repackagers and...

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 …

Classify Your Medical Device | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions 2. …

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 …

Overview of Regulatory Requirements: Medical Devices

    https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
    FDA was not comfortable with exempting all Class I devices, and there are still about 50 device types that require a 510 (k). We refer to those as Reserve Devices, but there are …

Medical Device Reporting (MDR): How to Report Medical …

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
    Mandatory Medical Device Reporting Requirements The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for …

Quality System (QS) Regulation/Medical Device Good …

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
    Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS …

Class I and Class II Device Exemptions | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions
    Devices which may not be subject to 510 (k) requirements include: Preamendments devices (please refer to FDA’s guidance “ Intent to Exempt Certain …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.5
    (b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.12
    (a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test …



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