FDAnews Announces — De Novo Strategies for Getting Your Medical Device Approved: What is the FDA Really Looking For? Webinar, Sept. 25, 2018

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Is de novo right approval pathway? Two top FDA lawyers explain best route for obtaining de novo classification.

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FDAnews

De Novo Strategies for Getting Your Medical Device Approved:
What is the FDA Really Looking For?
**An FDAnews Webinar**
Sept. 25, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/denovostrategies

What’s the best route for obtaining de novo classification?

What applications are being granted by the FDA?

What are the best practices to win approval?

These are some of the questions devicemakers need to ask when formulating their de novo approval strategy.

One of the best ways to win is to evaluate devices that have been brought to market via de novo. FDANews has invited two top FDA regulatory lawyers, Yarmela Pavlovic Esq. and Kelliann Payne Esq. of Hogan Lovells US LLP, to show devicemakers why and how to pursue it. Over the course of 90 informative minutes, attendees will:

  •     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

Risks of the de novo approach are low. Within 120 days, the FDA will determine if a device is Class I or II and may issue an entirely new product code and regulation number. If rejected, the device simply remains Class III. Here’s a chance to see how de novo works.

Meet the Presenters:
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. 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.

Who Will Benefit:

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

Webinar Details:
De Novo Strategies for Getting Your Medical Device Approved:
What is the FDA Really Looking For?
**An FDAnews Webinar**
Sept. 25, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/denovostrategies

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/denovostrategies                        
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
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