Simplifying Global Compliance
The 21st Century Cures Act’s Impact on Medical Devices - Webinar CD/Transcript
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The 21st Century Cures Act’s Impact on Medical Devices: What You Need to Know to Thrive in 2017
The passage of the 21st Century Cures Act means you 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 for a discussion on the biggest change in the daily activities of the device regulatory community in four decades.
After this 90-minute session you’ll 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 your 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 your competition
Order today and learn what has changed with the 21st Century Cures Act and what you need to watch for in your submissions to the FDA.
- Regulatory affairs professionals
- Product lifecycle managers
- Approval and submissions specialists
- Medical affairs
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.