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What information is required for a De Novo request?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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