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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:
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:
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.
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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