De Novo Submission
A De Novo submission is required for novel medical devices with no existing predicate, making them ineligible for the 510(k) pathway.
We support:
- Devices that receive Not Substantially Equivalent (NSE) determinations from the FDA
- Devices that intentionally pursue De Novo as the first route
Our team guides you through classification, submission requirements, and strategic preparation, helping you enter the US market with clarity and confidence.
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