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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-and-patient-decision-support-software
Provides clarity on the scope of FDA's regulatory oversight of clinical decision support software intended for healthcare professionals, and more.
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-clinical-decision-support-software-draft-guidance-11042019-11042019
Background: The purpose of this draft guidance is to describe FDA's regulatory approach to clinical decision support (CDS) software functions. The agency's approach includes recent changes to the...
https://healthitanalytics.com/news/fda-unveils-clinical-decision-support-medical-device-guidance
When it comes to clinical decision support, the line has been drawn according to provisions in the 21st Century Cures Act. “Generally, CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” explained Gottlieb.
https://www.chilmarkresearch.com/fda-guidance-clinical-decision-support/
Dec 19, 2017 · The FDA has released long-anticipated draft guidance on how they intend to regulate clinical decision support products. For applications with data originating from medical devices, the FDA will continue its oversight, AI or not (e.g., medical image processing).
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-clinical-decision-support-software-alerting-providers-potential-stroke
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients; Press Announcements
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