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…