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CDS Final Guidance Infringes On Free Speech, Professor Says

 
• By Hannah Daniel

A citizen petition filed by a University of Florida Law Professor posits that the FDA’s CDS Guidance violates the first amendment.

A physician looks over two screens with diagnostic images like a skeleton and MRI scan.
• Source: Shutterstock

The US Food and Drug Administration’s Clinical Decision Support Software final guidance infringes on physician free speech, law professor Barbara Evans says in a citizen petition recently filed with the agency.

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More from Policy & Regulation

South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

New Guidance From Canada’s HTA Agency On Submission Of AI-Driven Evidence

 
• By Neena Brizmohun

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.