The following sections should be included in your De Novo request:

• Administrative information: intended use statement, prescription vs. over-the-counter use
• Complete device description: technology, proposed conditions for use, accessories, components, etc.
• Regulatory history
• Change summary (if needed)
• Device labeling
• Classification information and supporting data: complete discussion of general controls and/or special controls; clinical data relevant for safety and effectiveness; nonclinical data and bench performance testing; information on reprocessing and sterilization, shelf life, biocompatibility, software, animal studies; description of probable benefits compared to anticipated risks
• Risk mitigation information