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FDA Clinical Decision Support Software Guidance Webinar

Brought to you by the AMIA Public Policy Committee

Deputy Director Mr. Brendan O’Leary of the Digital Health Center of Excellence at the FDA's Center for Devices and Radiological Health will present on the Clinical Decision Support Software, Guidance for Industry and Food and Drug Administration Staff that was issued September 28, 2022. Deputy Director O’Leary will provide a general overview of the CDS Guidance to educate and gain further awareness. He will further clarify FDA’s existing digital health policies continuing to apply software functions that meet the definition of a device, including those that are intended for use by patients or caregivers. There will be examples of how FDA applies the Device CDS criteria versus Non-Device CDS. 


  • What is the FDA CDS Guidance?
    - Background, Scope and Goals
  • Interpretation of Criteria
    - Four Criteria
      - Examples of Device CDS Software Functions
      - Examples of Non-Device CDS Software Functions 
  • What's Ahead?
  • Q & A


Brendan O'Leary
Deputy Director
Digital Health Center of Excellence at the FDA's Center for Devices and Radiological Health

Brendan O’Leary is Deputy Director of the Digital Health Center of Excellence (DHCoE) at FDA and led the DHCoE as its Acting Director throughout 2022. Over his nearly 14-year tenure with FDA, Mr. O’Leary has built an international reputation as an expert on digital health, medical device software, and diagnostic medical device evaluation, and he frequently represents FDA on these topics through numerous speaking engagements, press interviews, and interactions with Congress.

Mr. O’Leary is a strong advocate for policies that empower those who benefit from advanced safe and effective medical technologies, and he promotes regulatory approaches that improve medical device interoperability, improve user access to medical device data, provide users with more control over home-use medical devices, facilitate open-source development of medical device software, and appropriately increase over-the-counter access to medical technologies without a prescription.

Throughout his career, Mr. O’Leary has championed and led successful efforts to increase regulatory flexibility for lower-risk technologies while promoting policies and regulatory approaches that increase the use of safety-enhancing software engineering techniques in the medical technology industry, especially including software development practices related to continuous integration and continuous delivery (CI/CD). Mr. O’Leary has driven policy efforts to enable rapid modification and continuous learning techniques for artificial intelligence and machine learning technologies, and he worked with Congress and other stakeholders to extend these efforts to all medical devices with legislation passed and signed into law in December 2022.

Mr. O’Leary holds a B.S. in Mechanical Engineering from the University of Maryland, College Park. Before joining FDA, he designed and developed tools that were used by NASA astronauts to repair the Hubble Space Telescope.

Mr. O’Leary lives in Maryland with his wife, Jessica, and their dog, Bear.

Dates and Times: -
Type: Webinar
Course Format(s): Live Virtual
Price: Free
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