Frequently Asked Questions

What is included in a De Novo Pre-Sub?

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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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