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.
Trusted by top-tier teams worldwide
Featured case studies
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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