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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 this means in practice

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

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      The Abbreviated 510(k) Program
      Bot-blocked
      FDAfda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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