Can I read FDA Guidance on Clinical Decision Support Software on EtoBox?

FDA Guidance on Clinical Decision Support Software by leebc2023 is a document available to read on EtoBox.

What is FDA Guidance on Clinical Decision Support Software about?

The document provides guidance from the FDA regarding the regulation of Clinical Decision Support (CDS) software, clarifying which software functions are considered devices under the FD&C Act. It outlines criteria for distinguishing between device and non-device CDS software, emphasizing that not all CDS software is subject to FDA oversight. The guidance aims to help industry stakeholders understand the regulatory landscape for CDS software functions as per recent amendments to the law.

Author

leebc2023

Language

EN