Celesq® Programs

New Set of Guidance from FDA Provides Clarity on Digital Health Policies, Clinical Decision Support

Active
Program Number
29214
Program Date
2019-12-16

In September, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act. The long-awaited draft guidance on Clinical Decision Support (CDS) software sets forth FDAs proposed approach to regulating CDS, including software that incorporates machine learning (ML) technology. CDS is an emerging area for all fields of medical practice, including dermatology and oncology, and can be an invaluable tool for general practitioners to more effectively inform patient treatment. FDAs guidance provides numerous examples of CDS that it plans to regulate, those it does not, and software that is in between. This webinar will explore the limits of each.

Available in States

  • California
  • Georgia
  • New Jersey
  • New York
  • Texas Self Study

Program Categories

  • Administrative Law & Regulations
  • Bankruptcy Law & Creditor Rights
  • Constitutional Law
  • Federal Courts
  • Health Care Law
  • Pharmaceutical Law
  • Regulatory and Administrative Law