News & Insights


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 The final guidance follows two attempts at a draft guidance—in 2017 and 2019—and sets forth FDA’s interpretation of Congress’s directive to exempt CDS Software from the definition of a medical device and from FDA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

Event Details

Date: October 25, 2022

Time: 12:00 pm (ET)

Attend This Webinar

Please register soon. You do not have to be a client to attend, and there is no charge.