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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
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.

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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