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    Abbreviated 510(k)

    510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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

    Definition

    An Abbreviated 510(k) uses summary reports of compliance with relevant FDA guidance documents, special controls, or recognized consensus standards in lieu of submitting full underlying test data.
    What the regulation says
    The FDA introduced the Abbreviated 510(k) pathway to streamline the review process for certain devices by leveraging recognized standards and special controls. This approach is outlined in the FDA's guidance document, "The Abbreviated 510(k) Program for Certain Devices." Reviewers verify that manufacturers have adequately addressed all relevant aspects of the recognized standards or special controls, as detailed in 21 CFR 807 Subpart E.

    What this means in practice

    Useful for well-understood device types where standards substantially cover safety and performance. Reviewers still expect summary information demonstrating conformance.

    Examples

    • A manufacturer of a new sterile, single-use surgical glove might submit an Abbreviated 510(k) by demonstrating conformity to recognized consensus standards like ASTM D3577 for medical gloves.
    • For a dental amalgam alloy, an Abbreviated 510(k) could involve providing summary data showing compliance with ISO 24234, Dentistry, Amalgam alloys.
    • A blood glucose meter company might use an Abbreviated 510(k) by presenting a summary of compliance with ISO 15197 for in vitro diagnostic test systems for self-testing.
    Common pitfalls
    • •A common pitfall is the assumption that no testing data is required; instead, summary reports demonstrating conformance to recognized standards or special controls are necessary.
    • •Failing to adequately cite or demonstrate compliance with all applicable sections of relevant guidance documents or standards can lead to delays.
    • •Manufacturers sometimes incorrectly assume that an Abbreviated 510(k) is suitable for novel devices without clear predicate devices or recognized standards.
    • •Submitting an Abbreviated 510(k) without a thorough understanding of the specific requirements for summary reports can result in a request for additional information or a refuse to accept decision.

    Frequently asked questions

    The primary benefit is a more efficient and potentially faster review process, as it relies on summary reports of compliance with established standards or controls rather than detailed raw data submissions.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Grouped by theme

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    FDA·2RAPS·1
    1. 1
      The Abbreviated 510(k) Program
      Verified
      FDAfda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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