Breakthrough Designation Webinar


Heads turn and crowds make way for VIPs as they make their way down the red carpet. What if your medical device could receive this same treatment? The FDA Breakthrough Device Designation program is a way to roll out the red carpet for a device to follow to achieve commercialization. This discussion will provide insights to help you understand the FDA Breakthrough Device Designation program and determine whether this designation should be considered as part of your device development program. DuVal & Associates will share experiences and best practices to help you successfully navigate the Breakthrough Device Designation process to accelerate commercialization of your product that is worthy of VIP status.

In this program, we will cover the following topics:

  • Foundations and history of the Breakthrough Device Designation program
  • Breakthrough Device Designation Criteria
  • How to complete a Breakthrough Device Designation request
  • Maximizing benefits of a Breakthrough Device Designation

Featured Speakers:
Lisa Pritchard
BSEEE, DuVal & Associates

RAPS Twin Cities Webcast: Advertising and Promoting On- and Off-Label Information Under the FDCA

This webcast will cover the contours of the law, regulations, guidance, and court cases shaping how the U.S. Food and Drug Administration (FDA) views the current state of the law on promoting devices and drugs under the Food, Drug & Cosmetic Act. There will be a special focus on promoting 510(k) devices under FDA's General/Specific Use and 510(k) guidance documents, mostly related to determining what is on and off-label.

Featured Speakers:
Mark DuVal
President, DuVal & Associates
Aaron Hage
Associate Attorney, DuVal & Associates

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RAPS Regulatory Convergence 2018

Join DuVal & Associates President and CEO Mark DuVal at the RAPS Regulatory Convergence 2018 conference in Vancouver, British Columbia.

Mark will be speaking as part of a panel of experts during a workshop entitled "US Regulatory Essentials, Medical Devices and IVDs" on October 1st, 2018.

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