FDA Releases Guidance on Benefit-Risk Factors in Substantial Equivalence in 510(k) Submissions


A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.

Key Components of the guidance are:

  • Guidance in understanding if a device can be considered substantially equivalent when there are technological differences.

  • Clarification when a benefit-risk assessment comparing a new device to a predicate device may be needed.

  • Explanation of how the FDA assesses the risk of devices.

  • Descriptions of when performance data are required for submission.

  • No added burdens for submissions.

  • No change to the 510(k) review process.

The FDA will hold a question and answer webinar on November 1, 2018. Information about the webinar can be found here.


- The Clinical Pathways Team

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