Mobile Medical App Fda

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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 encourages the development of mobile medical apps (MMAs) that improve health care and provide consumers and health care professionals with …

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

Center for Biologics Evaluation and Research FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain …

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

Software functions (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory …

FDA Regulation of Mobile Medical Apps | Regulatory …

https://jamanetwork.com/journals/jama/fullarticle/2687221

Mobile Health and Telemedicine Narrative Medicine Nephrology Neurology Neuroscience and Psychiatry Notable Notes Nursing Nutrition Nutrition, Obesity, Exercise …

Policy for Device Software Functions and Mobile …

https://www.fda.gov/media/80958/download

Contains Nonbinding Recommendations. 1. Policy for Device Software Functions and Mobile Medical Applications Guidance for Industry and Food and Drug …

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

For Immediate Release: December 10, 2018 Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of …

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

Because these mobile apps are not considered medical devices, the FDA does not regulate them. The FDA understands that there may be other unique and …

Is Your Health Application Regulated by the …

https://jacksonllp.com/health-and-medical-apps-fda-regulation/

A mobile medical app is one that incorporates device software functionality and is intended to: be used as an accessory to a regulated medical device; or transform a …

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

Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application …

Examples of Software Functions for Which the FDA Will …

https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-software-functions-which-fda-will-exercise-enforcement-discretion

Mobile apps that are intended to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology; Mobile apps …

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