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U.S. Department of Health and Human Services

Medical Devices

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Appendix C: 510(k) Process

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The following outlines the process for industry to determine which type of 510(k) submission is appropriate for a new device (i.e, Special 510(k), Abbreviated 510(k), or Traditional 510(k)) and the process by which FDA reaches a final determination for all types of 510(k) submissions.

Industry
Originating step: intending to market a device for which a 510(k) is required.

A "Special 510(k): Device Modification" submission is appropriate if all of the following conditions are met:

  • The new device represents a modification to your own device
  • The new device has
    • the same indications for use as your predicate device
    • the same fundamental scientific technology
    • conformance with QSR
  • The modification(s) to the device are appropriate for reliance on results from design control process

Industry is responsible for completing design validation and assuring conformance. Refer to section V.A of the guidance document for additional information regarding the Special 510(k) Program.

An "Abbreviated 510(k)" submission is appropriate if the following condition is met:

  • There is a special control, guidance document, or recognized consensus standard for the new device and it has appropriate acceptance criteria.

Industry is responsible for assuring conformance. Refer to section V.B of the guidance document for additional information regarding the Abbreviated 510(k) Program.

A "Traditional 510(k)" submission should be submitted if you have intent to market a device for which a 510(k) is required and the criteria for the Special 510(k) or Abbreviated 510(k) submission do not apply.

FDA
Originating step: FDA receives a “Special,” “Abbreviated,” or “Traditional” 510(k) submission

FDA will conduct a review of the 510(k) submission to determine if the new device is Substantially Equivalent (SE) or Not Substantially Equivalent (NSE) to a predicate device. If the Decision Making Process results in a SE or NSE determination, the review of the submission is complete. If either SE or NSE decision cannot be determined following assessment of the 510(k) submission, FDA will request additional information. The 510(k) submitter’s response to the requests for additional information will be reviewed and assessed using the Decision Making Process to determine if the device is SE or NSE to a predicate device. FDA will issue requests for additional information and review the submitter’s response until a determination of SE or NSE can be made. Refer to Appendix A for the Decision Making Process used to determine equivalence.