FDAnews Announces — FDA’s New Device De Novo Reclassification Webinar, Feb. 9, 2016

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Is the de novo process right for a 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 manufacturers what they must do to ensure that the request includes all the data elements and supporting research the FDA requires.

FDA’s New Device De Novo Reclassification
Feb. 9, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/devicedenovo

Is the de novo process right for a medical device?

Perhaps.

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 manufacturers what they must do to ensure that the request includes all the data elements and supporting research the FDA requires.
Attend this session and three expert de novo attorneys from Hogan Lovells will quickly bring attendees up to speed. Attendees will 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 the 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, attendees will learn the key elements (and nuances) that will significantly improve the chances of getting a device cleared on its first review, including key questions manufacturers must answer and information that must be included in the 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, attendees will find out what to say in the all-important “classification summary” that shows a thorough research of 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 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.

Meet the 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.

Who Will Benefit:

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

Webinar Details:
FDA’s New Device De Novo Reclassification
Feb. 9, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/devicedenovo http://www.fdanews.com/devicedenovo?hittrk=16122VOCUS
Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/devicedenovo
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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