MedTech Terms
    The authoritative reference
    All terms

    De Novo Classification Request

    Pathway to classify novel low- to moderate-risk devices that lack a predicate.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    The De Novo classification process provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide a reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.

    What this means in practice

    Granting a De Novo creates a new device classification (Class I or Class II with special controls) and can serve as a predicate for future 510(k) submissions, shaping the regulatory framework for an entire device category. It is intended for novel devices where risk is low to moderate but no legally marketed predicate exists.

    Examples

    • The first cleared AI-based diabetic retinopathy screening software, which established a new device type and enabled subsequent 510(k) submissions.
    • A novel low-risk digital therapeutic classified into a newly created Class II product code with special controls.

    Use cases

    1 scenario
    1

    First-of-kind continuous glucose-trend wearable

    Regulatory strategist

    A wearable measures interstitial glucose trends but doesn't fit any existing product code. The sponsor receives a Not Substantially Equivalent decision on a 510(k), then files a De Novo with risk-based special controls.

    OutcomeFDA grants De Novo classification as Class II and creates a new product code, which becomes a predicate for future entrants.
    Common pitfalls
    • •Filing a De Novo when a plausible predicate exists. FDA may redirect the submission to a 510(k), losing months.
    • •Underestimating the special controls FDA may impose, which become binding on the applicant and future 510(k) followers.
    • •Skipping a Pre-Submission (Q-Sub) meeting to confirm De Novo is the correct pathway.

    Frequently asked questions

    De Novo fits novel low- to moderate-risk devices with no legally marketed predicate. If a predicate exists, use 510(k). If the device is high risk (Class III), use PMA.

    Cross-references

    Often confused with

    Distinct concept frequently mistaken for this one.

    Grouped by theme

    Primary references

    3 sources
    Link health: 2 verified 1 unchecked· last checked 2026-06-20
    FDA·2IMDRF·1
    1. 1
      De Novo Classification Request
      Verified
      FDAfda.gov
    2. 2
      Acceptance Review for De Novo Classification Requests
      Unchecked
      FDAfda.gov
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

    Inline markers like [1] jump to the matching reference above.