FDA’s Changing Approach to Regulating Clinical Decision Support Software

On September 28, 2022, FDA released a long-awaited final guidance document concerning the Agency’s policy for Clinical Decision Support Software (CDS Software). The final guidance follows two attempts at a draft guidance—in 2017 and 2019—and sets forth FDA’s interpretation of Congress’s directive to exempt CDS Software from the definition of a medical device and from FDA regulation. This webinar will:

• Provide an overview of the history of FDA’s attempts to set policy regarding the regulation of CDS Software
• Summarize the 2022 final CDS Software guidance
• Compare and contrast the 2022 final guidance with the 2017 and 2019 draft guidances
• Identify potential areas of concern for CDS developers

For questions, contact Twilah Robinson at trobinson@kslaw.com.