Searching for Fda Approval Clinical Decision Support information? Find all needed info by using official links provided below.
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/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
This guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for health care professionals, patients, or caregivers. FDA recognizes that the term...
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
https://hitinfrastructure.com/news/aha-speed-fda-approval-of-clinical-decision-support-algorithms
Dec 31, 2019 · The FDA recognized the importance of clinical decision support tools in recent draft guidance to implement Section 3060(a) of the 21st Century Cures Act, which aims to deter over-regulation of clinical decision support software by establishing criteria to exempt low-risk software from FDA regulation, while also ensuring control over software that replaces decision-making of …
https://www.aha.org/lettercomment/2019-12-20-aha-comments-fda-guidance-clinical-decision-support-software
The AHA commented on the Food and Drug Administration’s draft guidance for industry and FDA staff on clinical decision support software as part of the agency’s efforts to implement Section 3060(a) of the 21st Century Cures Act.
https://www.squirepattonboggs.com/~/media/files/insights/publications/2018/03/ahla-article-fda-approves-marketing-of-clinical-decision-support-software-for-stroke-triage-in-midst-of-renewed-focus-on-digital-health-applications/ahla_hit_alert_3818.pdf
The Food and Drug Administration (FDA) recently approved the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients.
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