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What is a De Novo?

A De Novo is an FDA device submission where you are requesting that the FDA create a new device regulation. This is required when a device has a different intended use or the differences in technological characteristics introduce new issues of risk that other devices on the market, for that same intended use, do not have. A De Novo uses the same FDA eSTAR template as a 510(k), but there are differences in what you have to include: 1. classification rationale as Class 1 or 2 2. a proposed regulation name and number 3. proposed special controls 4. draft benefit/risk analysis 5. risk mitigation table 6. alternative procedures and techniques to the subject device's technology 7. your efforts to identify a potential predicate device A De Novo usually requires clinical data to demonstrate safety and effectiveness, but a 510(k) rarely does. A De Novo also costs a lot more: $145,068 for the standard fee $36,267 for the small business fee The process for reviewing a De Novo also takes longer (~390 calendar days): https://medicaldeviceacademy.com/de-n... If you would like to discuss your potential De Novo project, please schedule a call on our contact us page: https://medicaldeviceacademy.com/cont...