FDAnews Announces — The 21st Century Cures Act’s Impact on Medical Devices: What You Need to Know to Thrive in 2017 Webinar, Jan. 26, 2017

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The passage of the act means devicemakers will be scrambling to meet new mandates, regulations and guidances in several key areas including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions. Join legal expert Jim O’Reilly on Jan. 26 for a discussion on the biggest change in the daily activities of the device regulatory community in four decades.

The 21st Century Cures Act’s Impact on Medical Devices:
What You Need to Know to Thrive in 2017
**An FDAnews Webinar**
Jan. 26, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/21stcenturycures        

What do manufacturers need to know about the 21st Century Cures Act in order to thrive this year?

The passage of the act means devicemakers will be scrambling to meet new mandates… regulations and guidances in several key areas — including data development and maintenance, technical support, clinical approvals, breakthrough devices, device inspections and reviews, and humanitarian device exemptions.

Join legal expert Jim O’Reilly on Jan. 26 for a discussion on the biggest change in the daily activities of the device regulatory community in four decades.

After this 90-minute webinar attendees will understand:

  •     How Congress has thrown a curve at the FDA’s often stringent review process, enabling far easier approval for lower-risk devices
  •     How to accelerate approval of new medical devices and still stay in compliance with current FDA regulation and guidance
  •     How the FDA intends to implement the new acceptance program for non-USA medical device research
  •     How the FDA is likely to interpret “least burdensome review”
  •     How the FDA is likely to interpret the humanitarian device exemption specifically mandated in the Cures Act
  •     How to develop cutting-edge strategies to maximize the numerous opportunities for more rapid device development under the Cures Act and not fall behind the competition

Register today and learn what has changed with the 21st Century Cures Act and what devicemakers need to watch for in their submissions to the FDA.

Meet the Presenter:
Jim O’Reilly, Retired Law Professor, University of Cincinnati College of Law

Longtime food and drug law professor Jim O’Reilly was quoted by the U.S. Supreme Court in a 2000 FDA medical device case as “the expert” on device law. He is the last surviving member of the small group which negotiated in 1975-76 for the Medical Device Amendments, and his 3-volume treatise for West “Food & Drug Administration” is used around the world by regulated firms. He chairs the FDA Committee of the American Bar Association and served for many years as program chair for conferences produced by the Food and Drug Law Institute. He served on the Editorial Advisory Board of FDLI’s Food and Drug Law Journal and has published 53 texts and 215 articles.

Who Will Benefit:

  •     Regulatory affairs professionals
  •     Product lifecycle managers
  •     Approval and submissions specialists
  •     Medical affairs

Webinar Details:
The 21st Century Cures Act’s Impact on Medical Devices:
What You Need to Know to Thrive in 2017
**An FDAnews Webinar**
Jan. 26, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/21stcenturycures        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/21stcenturycures                                        
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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Michelle Butler
FDANEWS
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