Draft Guidance Mobile Medical Applications

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 …

Guidances with Digital Health Content | FDA

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

Draft Guidance for Industry and Food and Drug …

https://www.duanemorris.com/site/static/mobile_medical_applications_draft_guidance.pdf

Mobile Medical Application (Mobile Medical App) For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition of “device” in section …

Draft Guidance for Industry and Food and Drug …

https://www.cdc.gov/cliac/docs/addenda/cliac0811/T_addendum_FDA_Draft_Guidance_for_Mobile_Medical_Devices.pdf

C. Mobile Medical Application (Mobile Medical App) For purposes of this guidance, a "mobile medical app" is a mobile app that meets the definition of "device" in section …

Mobile Medical Applications

https://downloads.regulations.gov/FDA-2011-D-0530-0108/content.pdf

Mobile Medical Applications _____ Guidance for Industry and Food and Drug Administration Staff Document issued on: September 23, 2013 The draft of this …

The regulation of mobile health applications - BMC …

https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-10-46

Abstract. In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications …

Draft Guidance for Industry and Food and Drug …

https://www.federalregister.gov/documents/2011/07/21/2011-18537/draft-guidance-for-industry-and-food-and-drug-administration-staff-mobile-medical-applications

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent …

Mobile Medical Applications FDA Draft Guidance

https://medicalmarcom.com/medical-device-marketing/mobile-medical-applications-fda-draft-guidance/

To receive ‘‘Mobile Medical Applications’’ from CDRH, you may either send an email request to [email protected] to receive an electronic copy of the document or send a …

FDA draft guidance on mobile medical applications

https://medicaldeviceslegal.com/2011/07/25/fda-draft-guidance-on-mobile-medical-applications/

The FDA proposes that the guidance is applicable to mobile medical applications or “mobile medical apps”, defined as. “a software application that can be …

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

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 …