USA – FDA finalizes which clinical decision software functions it regulates

The US Food and Drug Administration (FDA) announced that it has finalized guidance on which clinical decision software (CDS) functions it regulates as a medical device.

The agency released its latest position in the Clinical Decision Support Software document. The guidance clarifies the criteria in section 520(o) of the FD&C Act for identifying CDS functions that are not regulated as medical devices, known as non-device CDS. Notably, a software function must meet all four criteria to be excluded from the device definition…