De Novo Strategies for Getting Your Medical Device Approved - Webinar Recording/Transcript

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De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For?

Strategy is the key component in your de novo application.

You need to know:

  • What’s the best route for obtaining de novo classification?
  • What applications are being granted by the FDA?
  • What are the best practices?

FDAnews has invited a legal expert to explain it all. Over the course of 90 informative minutes, Kelliann Payne Esq. of Hogan Lovells US LLP will show you the upside — and downside — of seeking de novo approval. You’ll:

  • Understand the differences in regulatory pathways for more novel devices
  • Be up-to-date on the current timelines associated with FDA clearance or approval of novel medical devices
  • Be able to interpret recent de novo applications granted by FDA and best practices
  • Learn how to evaluate examples of devices brought to market via the de novo classification process
  • Understand the benefits of the pre-submission process for devices seeking de novo classification
  • Be able to navigate potential pitfalls in the FDA clearance and approval process

Will de novo work for you? Don’t miss out on your chance to get a better insight into de novo’s requirements and timelines.

  • Regulatory affairs/compliance
  • Product lifecycle managers
  • Approval and submissions specialists
  • Medical affairs
  • Legal counsel

Kelliann Payne Esq. is Counsel at Hogan Lovells US LLP focusing on FDA regulation of diagnostic and therapeutic devices. She reviews the accuracy of marketing claims; helps clients with preclinical and clinical programs; and leads due diligence reviews for investments and acquisitions.