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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 Device Software Functions and Mobile ...

Policy for Device Software Functions and Mobile Medical …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications
    FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain software, including device software functions and …

Policy for Device Software Functions and Mobile …

    https://www.fda.gov/media/80958/download
    Contains Nonbinding Recommendations. 3 Devices” 9. and “ Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for …

Does Your Mobile Medical App Need FDA …

    https://reinvently.com/blog/mobile-medical-application-approval-fda/
    Applications Requiring FDA Approval. Put simply, if that question used any of the words you would …

Examples of Device Software Functions the FDA Regulates

    https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates
    Possible product codes: Varies depending on the intended use and function of the parent medical device; see additional examples below of software functions that: …

Top FDA-Approved Mobile Health Apps

    https://www.docwirenews.com/future-of-medicine/top-fda-approved-mobile-health-apps/
    Mobile MIM. As one of the first-launched medical apps on Apple’s App Store, Mobile MIM is the first FDA-approved app for viewing images and making …

FDA permits marketing of mobile medical application for …

    https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder
    For Immediate Release: September 14, 2017. Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat …

FDA clears mobile medical app to help those with opioid …

    https://www.fda.gov/news-events/press-announcements/fda-clears-mobile-medical-app-help-those-opioid-use-disorder-stay-recovery-programs
    December 10, 2018. Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient …

Does Your Healthcare App Need FDA …

    https://www.fyresite.com/does-your-healthcare-app-need-fda-approval/
    Your app probably needs FDA approval if it’s classified as a medical device. The word “medical device” conjures up images of x-rays, heart-rate monitors, and …

Examples of Software Functions That Are NOT Medical …

    https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-are-not-medical-devices
    1 Medical purpose magnifiers are regulated either under 21 CFR 886.5840 - Magnifying spectacles ("devices that consist of spectacle frames with convex lenses …



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