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# FDA Mobile Medical App Software Policy
- URL: https://www.fdaweb.com/fda-mobile-medical-app-software-policy/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:01:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152842

FDA has published a guidance, *Policy for Device Software Functions and Mobile Medical Applications*, to inform manufacturers, distributors, and other entities about how the agency intends to apply its regulatory authorities to select software functions intended for use on mobile platforms or general-purpose computing platforms. “Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms,” the [document](https://www.fda.gov/media/80958/download?ref=fdaweb.com) says, “FDA is issuing this guidance document to clarify the subset of software functions to which FDA intends to apply its authority.”

The guidance says that consistent with the agency’s existing oversight approach that considers the functionality of the software rather than the platform, it intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended.

The guidance contents are Introduction, Background, Definitions, Scope, Regulatory Approach for Device Software Functions, Regulatory Requirements, and six appendices.