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510(k), De Novo or PMA? Understanding the FDA pathway before development starts

White paper

Which FDA pathway a product will use is often treated as a late submission-strategy question.

This paper walks through what distinguishes 510(k), De Novo and PMA in practice, why each implies a different evidence and testing burden, and why the pathway decision needs to shape development from the outset rather than being confirmed once the product is already built.

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Know your pathway before you plan your build.

If you're heading toward the US market, we can help establish which pathway actually fits your product — and what that means for the evidence you'll need to generate.

Discuss your FDA pathway