What information is required for a De Novo request?

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The following sections should be included in your De Novo request:

  • Administrative information: intended use statement, prescription vs. over-the-counter use
  • Complete device description: technology, proposed conditions for use, accessories, components, etc.
  • Regulatory history
  • Change summary (if needed)
  • Device labeling
  • Classification information and supporting data: complete discussion of general controls and/or special controls; clinical data relevant for safety and effectiveness; nonclinical data and bench performance testing; information on reprocessing and sterilization, shelf life, biocompatibility, software, animal studies; description of probable benefits compared to anticipated risks
  • Risk mitigation information
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About the Author
Proxima CRO Team
Dora Huang
Intern

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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