Device De Novo Reclassification

Device De Novo Reclassification - Webinar CD/Transcript

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Device De Novo Reclassification: FDA’s New Direct De Novo Petitions in Action

Is the de novo process right for your medical device?


To help manufacturers decide, FDAnews is pleased to present a 90-minute webinar CD and transcript that explains the new one-step de novo procedure and tell you what you must do to ensure that your petition includes all the data elements and supporting research the FDA requires.

Our three expert de novo attorneys from Hogan Lovells' Philadelphia office will quickly bring you up to speed. You'll get the details of the key issues surrounding the new process:

  • FDA’s evolving view of substantial equivalence and de novo reclassification
  • When a de novo reclassification petition 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 petition, such as:

  • Should the device be regulated as Class I or Class II?
  • Is it subject to 510(k) requirements?
  • 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.

With the new one-step process, the FDA is finally offering you a tantalizing opportunity to get your products approved and to market more quickly.  Take full advantage of it. Order 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
Jonathan Kahan is a partner and co-director of Hogan Lovells Food, Drug, Medical Device, and Agriculture group and has been practicing in FDA law for 40 years. His practice focuses primarily on assisting medical device companies in navigating the FDA regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices and biologics.

In addition to the daily counseling of clients in FDA-related matters, Jonathan represents many clients in administrative hearings and trials and in the federal courts.

Janice Hogan is the Managing Partner of Hogan Lovells' Philadelphia office and is co-director of their FDA/Medical Device practice. She focuses her practice primarily on the representation of medical device, pharmaceutical and biological product manufacturers before the U.S. Food and Drug Administration (FDA).  She is a biomedical engineer and focuses on regulatory counseling related to high technology medical products.

Prior to becoming an attorney, Janice held positions in marketing/marketing research for a major pharmaceutical manufacturer. She has authored articles regarding the medical device 510(k) review process, regulation of medical software, orphan drug regulation and medical device products liability.

Lina Kontos is an associate at Hogan Lovells US LLC based in Washington D.C.  Her practice focuses on medical device issues before the Food and Drug Administration.  Lina works with medical device manufacturers to develop regulatory strategies for obtaining FDA marketing clearance and approval for their devices. She assists companies in matters pertaining to product development, regulatory strategy and product submissions (pre-submissions, 510(k)s, IDEs, and PMAs), as well as providing advice on a variety of other device-related regulatory issues including issues related to wireless technology, advertising and promotion.

Lina holds a B.S. from Carnegie Mellon University in Mechanical Engineering and Biomedical & Health Engineering and a J.D. from Georgetown University Law Center.