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Implants and Prosthetics | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
    Implants and Prosthetics | FDA Implants and Prosthetics Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to...

Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research …

Breast Implants | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
    Breast implants are medical devices implanted under the breast tissue or chest muscle to increase breast size (augmentation) or to replace breast tissue that has …

Classify Your Medical Device | FDA - U.S. Food and …

    https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
    Classify Your Medical Device | FDA Classify Your Medical Device The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different …

Medical Device Tracking | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking
    Medical Device Tracking | FDA Medical Device Tracking Manufacturers are required to track certain devices from their manufacture through the distribution chain when they …

Overview of Device Regulation | FDA - U.S. Food and …

    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, …

How to Determine if Your Product is a Medical Device

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
    Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.3
    A device is regarded as an implantable device for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, …

Devices Approved in 2022 | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/pma-approvals/devices-approved-2022
    Devices Approved in 2022 | FDA Devices Approved in 2022 This page lists all medical devices approved through the CDRH Premarket Approval process (PMA) in …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.180
    Sec. 820.180 General requirements. All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably …



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