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De Novo Approval

De Novo is a classification pathway for first-of-a-kind low- to moderate-risk devices.

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Jan 13, 2026
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What are the De Novo and PMA pathways and how do they differ for novel neuromodulation devices?

The FDA offers two distinct non-510(k) routes for novel neuromodulation devices: De Novo, a classification pathway for first‑of‑a‑kind low‑ to moderate‑risk devices, and Premarket Approval (PMA), the ...