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

    https://www.fda.gov/Medical-Devices
    CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device safety.

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

Overview of Device Regulation | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Guidance Documents (Medical Devices and Radiation …

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products
    1 (800) 638-2041. (301) 796-7100. [email protected]. Information-Medical Devices / Radiation Products. Division of Industry and Consumer Education. CDRH-Center for …

An Introduction to FDA’s Regulation of Medical Devices

    https://www.fda.gov/media/123602/download
    Device Regulations • 21 Code of Federal Regulations (CFR): Parts 800-1050 ... • FDA regulates medical devices by evaluating safety and effectiveness • FDA classifies …

Code of Federal Regulations (CFR) | FDA

    https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr
    Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299. These final regulations codified in the CFR cover various aspects …

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

    https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances
    Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff. CDRH/CBER/OCP/CDER, July 2020. …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.5
    For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 801.5 Medical devices; adequate directions for use. …

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

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=803
    TITLE 21--FOOD AND DRUGS. CHAPTER I--FOOD AND DRUG ADMINISTRATION. DEPARTMENT OF HEALTH AND HUMAN SERVICES. …



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