Fda Mobile Medical App Guidance

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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 software, including device software...

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 …

Guidances with Digital Health Content | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content

Step 7: Does the Device Software Functions (DSF) and …

https://www.fda.gov/medical-devices/digital-health-center-excellence/step-7-does-device-software-functions-dsf-and-mobile-medical-applications-mma-guidance-apply

The Policy for Device Software Functions and Mobile Medical Applications notes that software functions that meet the definition of a device may be deployed on …

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 Obesity …

Mobile Health App Interactive Tool | Federal Trade …

https://www.ftc.gov/business-guidance/resources/mobile-health-apps-interactive-tool

Mobile medical apps that undergo FDA review will be evaluated according to the same regulatory standards and risk-based approach that the agency applies to other …

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

Software functions that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most …

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 …

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

The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related …

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