Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the definition of a medical device by the 21st Century Cures Act (Cures Act), many software functions continue to meet the definition of a medical device and are the focus of the Food and Drug Administration’s (FDA) regulatory oversight. Because a wide variety of software can be described as “decision support,” understanding the regulatory requirements that may apply to such software can be challenging.
Clinical Decision Support Software Frequently Asked Questions (FAQs) | FDA
Clinical Decision Support Software Frequently Asked Questions (FAQs)
This graphic provides a visual overview of certain policies described in the Clinical Decision Support Software guidance.
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