Simplifying Global Compliance
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.
