FDA De Novo Classification Process for Novel Medical Devices (2026)

What FDA De Novo Classification Process for Novel Medical Devices (2026) requires

The FDA De Novo classification process provides a pathway to classify novel medical devices for which there is no legally marketed predicate device, but whose risk profile is low to moderate (Class I or II). Successful De Novo requests establish a new classification regulation and permit the device to serve as a predicate for future 510(k) submissions.

Pillar: Medical & Healthcare · Authority: FDA (Center for Devices and Radiological Health) · Version: 1.0.0 · Last updated: 2026-05-20

Primary source: https://www.ecfr.gov/current/title-21/chapter-I/part-860

SHA-256 integrity: a2d69cd09860b87a745945d563af847ba8e8f8eb2cb428e1f010048a4bc0a4cd

Primary Citations — 4 traced to source

• Federal Food, Drug, and Cosmetic Act, Section 513(f)(2) (De Novo classification)
• 21 CFR Part 860 (Medical Device Classification Procedures)

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