Regulatory pathway · all topics

De Novo Classification Request

De Novo creates a new classification for a novel low-to-moderate risk device with no valid predicate. Submission under 21 CFR Part 860 Subpart D. Once granted, the De Novo device itself becomes the predicate for future 510(k) submissions in that classification. Average decision time was 158 days in FY2024. Required content includes risk-based device classification justification, special controls proposal, performance testing, and clinical data when needed.

Source

FDA, 'De Novo Classification Request' (21 CFR 860.200-260)

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

How MedTek OS handles this

Compass drafts the de novo classification request workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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