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Home Use Devices | FDA - U.S. Food and Drug …

    https://www.fda.gov/medical-devices/home-health-and-consumer-devices/home-use-devices
    A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both...

Home Health and Consumer Devices | FDA

    https://www.fda.gov/medical-devices/products-and-medical-procedures/home-health-and-consumer-devices
    Home Health and Consumer Devices FDA regulates medical devices that consumers use themselves without professional medical assistance in the same way as …

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 …

Home Use Devices Initiative | FDA

    https://www.fda.gov/medical-devices/home-use-devices/home-use-devices-initiative
    Through FDA’s efforts, additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers have been and continue …

Brochure - Home Healthcare Medical Devices: A …

    https://www.fda.gov/medical-devices/home-health-and-consumer-devices/brochure-home-healthcare-medical-devices-checklist
    Examples of some home healthcare devices are ventilators and nebulizers (to help breathing); wheelchairs; infusion pumps; blood glucose meters, apnea monitors, and …

Frequently Asked Questions About Home Use Devices

    https://www.fda.gov/medical-devices/home-use-devices/frequently-asked-questions-about-home-use-devices
    Fax: 1-800-FDA-0178 MedWatch Online Regular Mail: Use postage-paid FDA Form 3500 Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 Q: How do I clean my …

Medical Device Databases | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases
    Apr 6, 2022

At-Home OTC COVID-19 Diagnostic Tests | FDA

    https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests
    The table below lists FDA-authorized at-home OTC COVID-19 diagnostic tests, and includes information on expiration dates, who can use the test, and other …

Establishment Registration & Device Listing - Food and …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
    Medical Devices Databases This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA Note: …

Product Classification - Food and Drug Administration

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm
    FDA Home Medical Devices Databases This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket …



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