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

Tuesday, Sept. 25, 2018 · 1:30 p.m. - 3:00 p.m. EDT

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 two legal experts explain it all. Over the course of 90 informative minutes, Yarmela Pavlovic Esq. and 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.

Register now.

Who Will Benefit

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

Webinar plus Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus Audio Recording/Transcript
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$487

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24/7 Encore Presentation
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$287

add to cart

Audio Recording/Transcript
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$287

add to cart

 

 

 

Meet Your Presenters

Yarmela Pavlovic Esq.

Partner
Hogan Lovells US LLP

Yarmela Pavlovic Esq. is Partner at Hogan Lovells US LLP focusing on device regulation and premarket strategies. She has particular experience with FDA regulation of digital and mobile health technology, as well as medical software and applications, and works toward strategic plans that comply with government regulations while achieving clients’ business objectives.

Kelliann Payne Esq.

Counsel
Hogan Lovells US LLP

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.

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