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FDA and Pediatric Approval
This session will explore the relationship of the FDA and the Pediatric medical community and provide a forum for discussion.
Learning Objectives
  • Summarize the history of the FDA in pediatrics and why it matters.
  • Describe opportunities to be involved, how the FDA works, and who our contacts can be at the FDA level.
  • Explore future directions for interactions with the FDA and how best to advocate for pediatric and ACHD patients.
Session Chair(s)
Elizabeth Saarel, MD
Rohan Kumthekar, MD
What does it take to get something FDA approved in Pediatrics?
Presenter(s)Charles I. Berul, MD

TED Talk: History of FDA and Pediatrics
Presenter(s)John K. Triedman, MD

How can PACES advance Pediatric and ACHD device development for FDA approval?
Presenter(s)Anne M. Dubin, MD

Why is it important to have FDA approval in Pediatric and ACHD?
Presenter(s)George F. Van Hare, MD
Charles Berul:
  • Medtronic,Inc. (Research (Contracted Grants for PIs and Named Investigators only))
  • PeriCor, LLC (Ownership/Partnership/Principal)
John Triedman:
  • UpToDate, Inc. (Royalty Income)
  • SentiAR, Inc. (Honoraria/Speaking/Consulting Fee)
  • Biosense Webster, Inc. (Institutional payments for provision of technical training)
Anne Dubin:
  • UpToDate, Inc. (Royalty Income)
George Van Hare: Nothing Relevant to Disclose

To view all Heart Rhythm 2023 Faculty Disclosures, please click here.
Education Framework
n/a – non-clinical content
General Concepts
Communication Skills and Shared Decision Making
Availability: On-Demand
Cost: FREE
Credit Offered:
No Credit Offered
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