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