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    RegulatoryRegulated PathwaysSpecial 510(k)

    Special 510(k)

    Streamlined 510(k) for modifications to a manufacturer's own legally marketed device.

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

    Definition

    A Special 510(k) relies on design control procedures to support a determination of substantial equivalence for changes to the submitter's own predicate, with a target FDA review goal of 30 days.

    What this means in practice

    Best when the modification's effects can be assessed via verification and validation methods with well-established performance criteria. Not appropriate for changes to indications for use.

    Cross-references

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    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      The Special 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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