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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