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    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 the regulation says
    The FDA introduced the Special 510(k) to streamline the review process for modifications to a manufacturer's own previously cleared device. This submission type assumes the changes can be adequately evaluated through design control procedures, as outlined in 21 CFR 820.30, without raising new questions of safety and effectiveness. It is intended for changes that do not alter the fundamental technology or intended use, focusing on modifications verifiable through established performance data.

    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.

    Examples

    • A manufacturer updates the software of a cleared infusion pump to improve the user interface without changing the essential performance or safety algorithms, submitting a Special 510(k) supported by software verification and validation documentation.
    • A company modifies the material of a component in a cleared surgical instrument to enhance durability, demonstrating equivalence through material testing and biocompatibility data via a Special 510(k).
    • A MedTech firm makes a minor dimensional change to a cleared orthopedic implant that does not affect its fit or function, submitting a Special 510(k) with engineering analyses and test results.
    Common pitfalls
    • •A common pitfall is submitting a Special 510(k) for changes that significantly alter the device's technology or intended use, leading to a rejection or a request for a Traditional 510(k).
    • •Misjudging the appropriate level of verification and validation needed for the modification can result in an incomplete submission.
    • •Failing to clearly document the link between the design changes and the supporting verification and validation activities is a frequent mistake.
    • •Assuming a 30-day review timeline is guaranteed, as the actual review time can be longer if deficiencies are identified.
    • •Submitting a Special 510(k) for modifications that introduce new risks or significantly impact patient safety is inappropriate and will be rejected.

    Frequently asked questions

    A Special 510(k) is appropriate for modifications to your own cleared device where the changes can be assessed through design controls and established performance criteria, such as material changes, sterility changes, or software enhancements that do not alter the indications for use.

    Cross-references

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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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