FDA’s Device De Novo Reclassification - Webinar CD/Transcript

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FDA’s Device De Novo Reclassification

Is the de novo process right for your medical device?


To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar on Feb. 9 that will explain the de novo procedure and tell you what you must do to ensure that your request includes all the data elements and supporting research the FDA requires.

Attend this session and our three expert de novo attorneys from Hogan Lovells will quickly bring you up to speed. You'll get the details of the key issues surrounding the process:

  • FDA’s evolving view of substantial equivalence and de novo reclassification
  • When a de novo reclassification request is appropriate
  • When and how to use the pre-submission process
  • Making effective risk/benefit arguments that will pass FDA muster
  • How the shift in timelines for review could affect your lifecycle planning and subsequent launch plans
  • What happens after an initial de novo clearance, both for subsequent modifications and for competitive products in the same classification
  • And more

Specifically, you'll learn the key elements (and nuances) that will significantly improve your chances of getting your device cleared on its first review, including key questions you must answer and information you must include in your request, such as:

  • Should the device be regulated as Class I or Class II?
  • What must be included in the proposed special controls document
  • Supporting protocols and data
  • Summary of benefits and potential risks
  • Risk and mitigation information

And, you'll find out what to say in the all-important “classification summary” that shows you have thoroughly researched the legally marketed devices and concluded that no appropriate predicate exists.

Now that the one step de novo process has been in action for some time with devices cleared via the direct de novo pathway, find out about best practice tips and tricks to get your products to market more quickly.  Take full advantage of it. Sign up for this invaluable update on the new and improved de novo clearance process.

  • Regulatory affairs professionals
  • Product lifecycle managers
  • Approval and submissions specialists
  • Medical affairs
  • Personnel new to the industry

Meet Your Presenters

Yarmela Pavlovic is a Partner in Hogan Lovells’ San Francisco office.  Her practice focuses primarily on the U.S. Food and Drug Administration (FDA)'s premarket regulation of medical devices. She works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing approval for their devices.

Kelliann Payne is Counsel with Hogan Lovells’, Philadelphia office. Her work focuses on issues related to medical devices. Her experience includes the development, regulation, advertising and litigation of medical devices.  Kelliann's work includes drafting premarket submissions for diagnostic and therapeutic medical devices, as well as evaluating applicable regulatory strategies for medical devices.

Lina Kontos is Counsel in Hogan Lovells’ Washington, D.C. office.  Lina works exclusively on medical device regulatory matters before the FDA, with a focus on the premarket clearance and approval of new medical devices.