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FDA De Novo Process for IVD Companies
FDA De Novo Process for IVD Companies

Our Price: $395.00

Product Code: WB7

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Contains video file.

The De Novo Process is the evaluation of automatic class III designation of devices. Using the De Novo Process could allow companies to submit a 510(k) for a new IVD that would otherwise have to get to the market via the PMA Process. This webinar will give an overview of the De Novo Process, discuss when it should be used, and give an FDA perspective on the advantages and overall process.
  • What is the De Novo Process?
  • When this process is used?
  • Overview of the process
  • Advantages of De Novo Process

Kathleen Simon, Ph.D
Reviewer, Microbiology Division, Office of In-Vitro Diagnostics/Center for Devices and Radiological Health

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