Navigation Links
FDAnews Announces — FDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software Webinar, April 7, 2020
Date:4/2/2020

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/cdssoftwareregulation

Tuition:
$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

Read the full story at https://www.prweb.com/releases/fdanews_announces_fda_cds_software_regulation_the_latest_guidance_on_clinical_decision_support_software_webinar_april_7_2020/prweb17024791.htm.


'/>"/>
Source: PRWeb
Copyright©2020 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Management Report: Managing Contract Manufacturers and Testing Labs
2. FDAnews Management Report: Implementing Risk-Based Verification and Validation
3. FDAnews Announces CDRH’s Office of Compliance Reorganization: A “One-On-One” with Office Director Steve Silverman, Webinar, Feb. 5, 2014
4. FDAnews Announces Device Software Verification and Validation: Get Ready for a New Breed of Investigators, On-Demand Webinar, Aug. 12, 2014
5. FDAnews Announces — Improving Your FDA Import Success Rate: Tips for Thinking Ahead of the FDAWebinar, Aug. 7, 2014
6. FDAnews Announces — Choosing the Right Drug Name: How to Increase Your Chances for Approval Webinar, July 22, 2014
7. FDAnews Announces — New Job Board Now Available on FDAnews.com
8. FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC
9. FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
10. FDAnews Announces Choosing the Best Device Sample Size for Verification and Validation: Tools to Safely Speed Your Device to Market, On-Demand Webinar, Aug. 27, 2014
11. FDAnews Announces — What to Do Now for UDI: Don’t Lose Your Customers by Getting Locked Out of the Market Webinar, Sept. 9, 2014
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2020)... ... 26, 2020 , ... As much of the country continues ... are joining forces to start a country-wide movement of physical activity to honor ... #FitForTheFrontLine is a national fitness challenge beginning Tuesday, May 26 and culminating on ...
(Date:5/21/2020)... ... , ... In response to the Coronavirus pandemic, Industrial Magnetics, Inc.(IMI) has developed ... doors without using their hands or fingertips. , The new Arm-Pull attaches ... forearm, wrist or elbow when entering or exiting a room. , Perfect for public ...
(Date:5/21/2020)... , ... May 21, 2020 , ... ... years of experience of GSCG, VITA NOVAS has already gained ground with the ... , vitamins and stimulating biological products intravenously, guaranteeing an effective way for the ...
(Date:5/21/2020)... ... May 21, 2020 , ... In response to ... lifted on May 28th and all businesses will be required to have covid-19 ... to work. , As an essential business, AmeriCare Medical began this precautionary process ...
(Date:5/21/2020)... (PRWEB) , ... May 21, 2020 , ... ... its award-winning population health management platform that supports care management and utilization management ... 100 individuals at client sites, TruCare 2020 provides significant usability and automation upgrades ...
Breaking Medicine News(10 mins):
(Date:5/21/2020)... ... May 21, 2020 , ... After The World ... telehealth solutions in order to continue seeing patients despite lockdowns and stay at ... for virtual care and complete healthcare communications, conducted online by The Harris Poll ...
(Date:5/21/2020)... ... May 21, 2020 , ... MedVet, a leader in ... veterinary hospital located at 601 Showers Dr., Mountain View, CA in June 2020. MedVet ... access for pet care in the Silicon Valley and broader Santa Clara County areas. ...
(Date:5/21/2020)... MARBLEHEAD, Mass. (PRWEB) , ... May 21, 2020 ... ... and the GLO Good Foundation today announced a unique set of ... protective equipment (PPE) donation levels to frontline healthcare. While millions of PPE units ...
Breaking Medicine Technology: