FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software

Webinar (ET)

Bradley Merrill Thompson, Member of the Firm, will present "FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software," a webinar hosted by FDAnews.

Join FDAnews and attorney Bradley Merrill Thompson for a comprehensive overview of current guidance on CDS software:

  • Learn about FDA regulation of AI used to guide clinical management of the Coronavirus
  • Master the legal, regulatory, and compliance nuances of the FDA’s guidance
  • Determine what types of CDS software functions do not meet the definition of a device as amended by the Cures Act
  • Assess which types of software meet the definition of a device for which the FDA may not enforce compliance under device requirements
  • Comprehend how the FDA intends to leverage the Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations External Link Disclaimer (IMDRF Framework) in its risk-based approach to CDS regulation

For more information, please visit FDANews.com.