Mobile Medical Applications Guidance For Industry

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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 Including Mobile Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications

Mobile apps can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need …

Mobile Medical Applications; Guidance for Industry and …

https://www.federalregister.gov/documents/2013/09/25/2013-23293/mobile-medical-applications-guidance-for-industry-and-food-and-drug-administration-staff

Mobile Health App Interactive Tool | Federal Trade …

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

Device software function, including mobile medical app. FDA refers to software functions that are medical device functions as “device software functions.” …

FDA Policy for Mobile Medical Applications

https://www.thehealthlawticker.com/fda-policy-for-mobile-medical-applications

In the Guidance, the FDA has broadened the scope of regulatory oversight by expanding the meaning of software applications to include mobile applications. 3 Specifically, the agency …

Devices Guidances | FDA

https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/devices-guidances

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Guidance for …

Mobile Medical Devices - SOCRA Blog

https://www.socra.org/blog/mobile-medical-devices/

Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (2015) lists two types of medical apps: enforced and unenforced (Table 2). Mobile medical apps that pose a …

Contains Nonbinding Recommendations Mobile …

https://research.unc.edu/wp-content/uploads/sites/61/2016/10/Mobile-Medical-Applications-FDA-Guidance-9-25-2013.pdf

Mobile Medical Applications __________________________ Guidance for Industry and Food. and Drug Administration Staff. Document issued on. February 9, …

Mobile Medical Applications Guidance For Industry And Food …

https://www.family-medical.net/mobile-medical-applications-guidance-for-industry-and-food-and-drug-administration-staff/

The guidance represents the Agency's current thinking on mobile medical applications. It does not create or confer any rights for or on any person and does not operate to bind …

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