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What is included in a De Novo Pre-Sub?
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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.

It is suggested that a Pre-Sub prior to a De Novo request include:

  • Proposed Class I or II
  • Regulatory research on relevant product codes
  • Specific questions regarding the request
  • Identified risks to health associated with the device and risk profile
  • Information regarding safety and effectiveness of the device
  • Protocols for nonclinical and clinical studies
  • Proposed mitigation controls for each risk

Some examples of questions to pose during your Pre-Sub meeting with the FDA include:

  • Based on the information provided, does FDA believe the device is eligible for De Novo classification?
  • Are there other risks, in addition to those identified in the Pre-Sub, given the indications for use for the device?
  • If applicable, are there controls that should be considered to provide a reasonable assurance of safety and effectiveness for the device?
  • If clinical data are needed, are the proposed study design and selected control group appropriate?

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