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# FDA Software Guidance Discussed
- URL: https://www.fdaweb.com/fda-software-guidance-discussed/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145202

A recent FDA policy guidance on medical device software says the agency will exercise enforcement power over three distinct types of software functions, one of which is specifically directed at mobile applications — functions that transform a mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Attorney **Michelle Bufano** (Patterson Belknap Webb & Tyler) writes in an online [post](https://www.lexology.com/library/detail.aspx?g=352ff72a-1c62-4d80-bb2c-e9e0ff9b6c91&ref=fdaweb.com) that software functions that use attachments, display screens, sensors, or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.

Bufano writes that what is even more interesting are the types of healthcare apps for which FDA does not intend to enforce requirements under the Federal Food, Drug, and Cosmetic Act, even though the agency acknowledges that these apps likely fall within its regulatory purview. The examples she lists are: patient self-management apps, apps that automate simple tasks for healthcare providers, apps that provide prompts or coaching to assist patients in managing their health, apps that provide information related to a patient’s condition, apps used to help capture patient data for healthcare providers, and apps that perform simple calculations routinely used in clinical practice.

“Presumably FDA decided to exercise its enforcement ‘discretion’ with respect to these non-diagnostic apps because they are considered a lower risk to patient health and safety,” she writes.

Bufano notes that the guidance is silent as to the privacy and data security issues raised by digital health applications, many of which collect and use very sensitive personal data, although the agency’s cybersecurity recommendations is likely to govern the apps over which FDA is exercising regulatory authority.