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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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