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CDS Final Guidance Draws More Criticism, This Time From Congress

 
• By Hannah Daniel

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

• Source: Shutterstock

Senator Bill Cassidy’s (R-LA) letter to the US Food and Drug administration calls into question the agency’s statutory authority to regulate clinical decision support (CDS) software as a medical device.

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More from Regulation

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.