At a glance
What this entry covers
FDA’s guidance Policy for Device Software Functions and Mobile Medical Applications explains which software functions, including mobile apps, FDA regulates as medical devices and where it intends to apply enforcement discretion to lower-risk functions. First issued in 2013, it was last updated in September 2022. It is addressed to developers and manufacturers of device software functions, including mobile medical apps.
MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid. It is not legal advice and is not a substitute for the official text.
Official documentation
- Primary official source: https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications
- FDA, Guidances with Digital Health Content: https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
Recent changes
- 2026-01-29: FDA issued final guidance Clinical Decision Support Software. FDA
- 2026-01-06: FDA issued final guidance General Wellness: Policy for Low Risk Devices. FDA
How to use this index entry
- Open the official link above (or the agency home if the deep link drifts).
- Confirm edition / revision date against your program scope.
- Map applicability by sector and jurisdiction listed in the metadata.
- Follow related frameworks only after checking their own official sources.
Disclaimers
- MyRHC does not host proprietary standards text (ISO, some industry bodies).
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- Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice.
MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.