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Remanufacturing and Servicing Medical Devices | FDA

    https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices
    Draft GuidanceThe distinction between "remanufacturing" and "servicing" is important to under…Papers and Reports1. Servicing Discussion Paper: Strengthening Cybersecurity Practices A… See more

FDA Rules and Regulations | FDA - U.S. Food and Drug …

    https://www.fda.gov/regulatory-information/fda-rules-and-regulations
    On this page: As required by law, the Food and Drug Administration publishes regulations in the Federal Register, the federal government's official publication for …

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

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

Jobs and Training at FDA | FDA - U.S. Food and Drug …

    https://www.fda.gov/about-fda/jobs-and-training-fda
    The Food and Drug Administration’s (FDA) mission is to protect and advance public health by helping to speed innovations that provide our nation with safe 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.

Who Must Register, List and Pay the Fee | FDA

    https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee
    Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register …

Quality and Compliance (Medical Devices) | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices
    In meeting this charge, the FDA promotes the development and production of high-quality medical devices. The FDA also recognizes that proper maintenance, repair, and …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=112&showFR=1&subpartNode=21:2.0.1.1.12.3
    Sec. 112.22 What minimum requirements apply for training personnel who conduct a covered activity? (a) At a minimum, all personnel who handle (contact) covered …

Overview of Regulatory Requirements: Medical Devices

    https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
    This is a requirement for all finished device manufacturers, as well as importers of medical devices. Manufacturers must also list their medical devices with the FDA at the time they …

Sterilization for Medical Devices | FDA

    https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
    Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other …



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