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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.

Clinic 52
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Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. And we can talk about that later in terms of potential clinical implications that may have code. How do you think about this from a clinical perspective when you’re seeing individuals in your office?

IT 120
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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.