The Beat Episode 10: Understanding the FDA’s Role in Regulating Medical Devices & The Role of Practicing Clinicians in the Device Surveillance Process (On-Demand)

[ON DEMAND] Join the Heart Rhythm Society and the U.S. Food and Drug Administration (FDA) for an overview of the agency’s role in regulating medical devices. During this webinar panelists will discuss regulatory pathways used to determine safety and effectiveness of medical devices, and strategic initiatives underway to quickly introduce new technology into the marketplace. The panelist will also provide information on collaborative opportunities for investigators, how recalls are determined, and more.

Learning Objectives

At the conclusion of the webinar, participants will be able to:

• Describe what the FDA does to protect public health.
• Describe device classifications and FDA regulatory processes for new technology.
• Discuss collaborative opportunities for investigators to engage in new technology studies.
• Explain collaborative opportunities for investigators, the role of practicing clinicians in reporting device malfunctions, and how recalls are determined.

Participants

Moderator

David J. Slotwiner, MD, FHRS | New York Presbyterian Queen

Panelists

Captain Brian Lewis, MD | U.S. Food and Drug Administration
Sara Royce, PhD | U.S. Food and Drug Administration
Amit J. Shanker, MD, FHRS | St Lawrence Health System
George Van Hare, MD | U.S. Food and Drug Administration