Final Clinical Decision Support Software Guidance Expands Info on Functions Not Regulated as Devices
September 29, 2022 at 01:11 PM EST
The FDA has issued final guidance intended to help clinical decision support (CDS) software developers understand whether their software products are subject to the agency’s regulatory oversight.
CDS software helps health care providers make decisions about the diagnosis, treatment, prevention, cure or mitigation of diseases or other conditions.
With the enactment of the 21s... Read More
