Non-device-MDDS

Since the 21st Century Cures Act, these functions are excluded from the device definition in the US. Once the software analyzes data, generates alarms or controls a device, it is no longer a non-device MDDS.

Software functions that are solely intended to transfer, store, convert formats, or display medical device data and results.

FDA guidance: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (September 2022), Section III, Definitions