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

    https://www.fda.gov/Medical-Devices
    Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center and the entire FDA ...

Wireless Medical Devices | FDA

    https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices
    Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to …

Classify Your Medical Device | FDA

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

Device Software Functions and Mobile Medical …

    https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
    The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps. The Policy for …

Expanded Access for Medical Devices | FDA

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices
    Expanded access to an investigational device under the emergency use mechanism is intended to provide patients and physicians with access to investigational …

Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: …

FDA Guidance on Wireless Devices: What …

    https://www.mddionline.com/regulatory-quality/fda-guidance-wireless-devices-what-you-need-know
    The guidance provides insight into FDA’s expectations with respect to premarket submissions and design protocols of wireless medical devices and sets a …

Securing Internet-Connected Medical …

    https://www.nist.gov/blogs/manufacturing-innovation-blog/securing-internet-connected-medical-devices
    For us, the new normal involves the accelerating adoption of internet-connected medical devices and virtual care models — the “internet of …



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