Fda Draft Guidance Mobile Medical Applications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

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 valuable …

Guidances with Digital Health Content | FDA

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

Draft Medical Device Guidance | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/draft-medical-device-guidance

Jan 30, 2023

Search for FDA Guidance Documents | FDA - U.S. Food …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results …

Draft Guidance for Industry and Food and Drug …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

To receive “Mobile Medical Applications” from CDRH, you may either send an e-mail request to [email protected] to receive an electronic copy of the document …

Clinical Decision Support Software Guidance for …

https://www.fda.gov/media/109618/download

policies described in the following guidances: Policy for Device Software Functions and Mobile Medical Applications,16Software as a Medical Device (SaMD): Clinical …

Draft Guidance for Industry and Food and Drug …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Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Applications This draft guidance when finalized will represent the Food and Drug …

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

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 …