Class: NP

** Reviewed the FDA’s “Policy for Device Software Functions and Mobile Medical Applications”**

https://www.fda.gov/media/80958/download

This guidance discusses FDA’s approach to regulating medical device software.

FDA regulatory approach looks at the function rather than the platform. Bins software as: 1. Software functions that are not medical devices 2. Software for which FDA intends to exercise enforcement discretion 3. Software that is the focus of FDA’s oversight: i. Software that transforms a mobile platform into a regulated medical device (typically via a mobile app) eg by connecting sensors/leads for an ECG, as an electronic stethoscope, to measure physiological parameters during CPR (eg using accelerometer), and like a dozen more examples in the guidance. ii. Software that connects to an existing device (eg implant or wearable device), eg altering function/settings of an infusion pump or neurostimulator or cochlear implant, controls inflation of a blood pressure cuff, or used to calibrate hearing aids. iii. Software used in active patient monitoring (Particularly focused on information that is used for an immediate medical response, eg monitoring of labor progress, bedside / cardiac monitors, clinical test equipment that provides recommendations for treatment, etc etc.)

Explicit callouts that phone vendors, app store vendors, and suppliers of support tools are not in scope as a medical device manufacturer just because their platform was used to support a device.

Also some discussion of the historical changes in the last ~15 years. eg some exemptions that were added to FD&C (that we discussed over in [[09272407361 RN FDA Webinar Digital Health]])