Draft Guidance For Industry Mobile Medical Applications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

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

Draft Guidance for Industry and Food and Drug …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

Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications This draft guidance when finalized will represent the Food and Drug …

Draft Guidance for Industry and Food and Drug …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

Guidances with Digital Health Content | FDA

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

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 …

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 FDA is issuing this guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select …

Clinical Decision Support Software | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

The final guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including …

Content of Human Factors Information in Medical Device …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions

This draft guidance document provides the FDA’s recommendations on the human factors information that should be documented and included in medical device …

Mobile Medical Applications FDA Draft Guidance

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

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 the …

FDA draft guidance on mobile medical applications

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

A very important final point in the draft guidance is that the FDA expects distributors of mobile medical apps who may or may not be a platform or service provider …