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    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 September 19, 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. A granted De Novo creates a new classification regulation and product code, so the device can then serve as a predicate for future 510(k) submissions. Requirements are set out in 21 CFR Part 860, Subpart D.
    What the regulation says
    The US De Novo pathway is authorized by section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360c(f)(2)). Its implementing requirements appear in 21 CFR Part 860, Subpart D. FDA published the final rule establishing these requirements on October 5, 2021, with an effective date of January 3, 2022. The pathway permits classification into Class I or Class II when general controls, or general and special controls, provide reasonable assurance of safety and effectiveness. A requester may apply directly, without first submitting a 510(k), or following an FDA determination that the device is not substantially equivalent. For MedTech manufacturers, the request must describe the device and intended use, justify the proposed classification, and provide evidence supporting safety and effectiveness, including clinical data when needed. It must address device risks and the controls proposed to mitigate them. FDA conducts an acceptance review before substantive evaluation; acceptance does not authorize marketing. Granting the request authorizes marketing and establishes a classification that can support subsequent 510(k) submissions using the device as a predicate. FDA guidance explains agency expectations but does not itself create legally binding requirements.

    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.

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    Learning paths (3)

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

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

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