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?
