Unpacking the FDA's Revised CDS and General Wellness Product Guidances - On Tech Ethics

Discusses key takeaways from the U.S. Food and Drug Administration’s revised Clinical Decision Support Software and General Wellness Product guidance documents. 

 
Our guests today are Christina Kuhn and Olivia Dworkin from the law firm Covington. Christina advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Olivia minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. 
 

Additional resources: 

• FDA’s Clinical Decision Support Software guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software 
• FDA’s General Wellness: Policy for Low Risk Devices guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices 
• 5 Key Takeaways from FDA’s Revised Clinical Decision Support (CDS) Software Guidance: https://www.cov.com/news-and-insights/insights/2026/01/5-key-takeaways-from-fdas-revised-clinical-decision-support-cds-software-guidance 
• FDA Issues Revised Guidance on General Wellness Products: https://www.cov.com/en/news-and-insights/insights/2026/01/fda-issues-revised-guidance-on-general-wellness-products 
• Covington Digital Health Blog and Resources: https://www.cov.com/en/practices-and-industries/industries/digital-health 
• CITI Program’s Essentials of Software as a Medical Device and Clinical Decision Support Systems: https://about.citiprogram.org/course/essentials-of-software-as-a-medical-device-clinical-decision-support-systems/ 
•  CITI Program’s course catalog: https://about.citiprogram.org/course-catalog