Devices

Clinical Decision Software Guidance

FDA has published a guidance, Clinical Decision Support Software, to clarify the scope of the agency’s oversight of clinical decision support (CDS) software intended for healthcare professionals. “Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device,” the document says.

FDA says its approach to CDS software functions reflects changes to the Federal Food, Drug, and Cosmetic Act made by the 21st Century Cures Act that excluded certain software functions from the device definition.

“The focus of this guidance is to clarify the types of CDS software functions that are excluded from the definition of device…,” it says. “This guidance further clarifies that FDA’s existing digital health policies continue to apply to software functions that meet the definition of a device, including those that are intended for use by patients or caregivers.”

The guidance says it provides many examples of how FDA intends to consider different kinds of software functions, including non-device CDS software functions and device software functions.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome