Adapting To FDA's Proposal For Diagnosis Support Software

Author:Ms Allison Fulton
Profession:Sheppard Mullin Richter & Hampton
 
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With the rise of artificial intelligence and machine learning, clinical decision support, or CDS, software presents a novel opportunity to analyze immensely large amounts of data for patterns or other information that may be relevant to a particular patient's diagnosis or health care options.

In late September, the U.S. Food and Drug Administration published a draft guidance on clinical decision support software that sets forth the agency's proposed approach to regulating CDS, including CDS that incorporates machine learning technology.

Companies developing CDS software for life science or other medical applications should review the FDA's planned approach, and the numerous examples provided, to understand how the FDA intends to...

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