Clinical Decision 2021 - FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software Training

Does your software provide computerized alerts and reminders for providers and patients? Or clinical guidelines, condition-specific order set, focused patient data reports and summaries, documentation templates, diagnostic support or contextually relevant reference information?
You need to have a good grasp of the latest legal, regulatory and compliance nuances of FDA’s guidance on CDS software to be able to clarify the type of CDS software functions affected by legal developments like the 21st Century Cures Act.
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
Speaker:
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant.