FALLS CHURCH, VA. (PRWEB) APRIL 02, 2020
FDA CDS Software Regulation:
The Latest Guidance on Clinical Decision Support Software
An FDAnews Webinar
Tuesday April 7, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/cdssoftwareregulation*NEW: The webinar will be updated to include FDA regulation of AI used to guide clinical management of the Coronavirus.*
Is one’s software regulated as a medical device?
Does it provide computerized alerts and reminders for providers and patients, documentation templates, diagnostic support or contextually relevant reference information? Then, the software might be regulated as a medical device.
Join FDAnews and legal expert Bradley Merrill Thompson for a comprehensive overview of the latest legal, regulatory and compliance nuances of FDA’s guidance on clinical decision support (CDS) software:
•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
Establish compliant best practices for CDS software by understanding the legal, regulatory and compliance nuances of the FDA’s guidance.
Webinar Details:
FDA CDS Software Regulation:
The Latest Guidance on Clinical Decision Support Software
An FDAnews Webinar
Tuesday April 7, 2020, 1:30-3:00 p.m. EDT
https://www.fdanews.com/cdssoftwareregulationTuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/cdssoftwareregulation
By phone: 888.838.5578 or 703.538.7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations
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