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...