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# 510(k) Substantial Equivalence Guidance Explained
- URL: https://www.fdaweb.com/510-k-substantial-equivalence-guidance-explained/
- Published: 2018-11-13T12:00:00.000Z
- Updated: 2026-09-15T00:44:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142814

CDRH biomedical engineer **Ifeanyi Uwemedimo** told a CDRH [Webinar](https://www.fda.gov/downloads/Training/CDRHLearn/UCM625605.pdf?ref=fdaweb.com) that comments received on a 2014 draft guidance on benefit risk factors to consider when determining substantial equivalence (SE) in premarket notifications with different technological characteristics fell into three broad groupings. In finalizing the guidance that was issued 9/25, FDA clarified that it does not change the current 510(k) review process or SE standard. It also clarified that benefit-risk assessment does not imply submission of clinical data, and it clarified what is expected in a 510(k) benefit-risk assessment.

The final guidance outlines the policy for evaluating substantial equivalence in a 510(k) when the benefit-risk profile of a new device is different from that of a predicate device based on the performance data, Uwemedimo said. The guidance also specifies two situations when a benefit-risk assessment is recommended — when there is an increase in risk along with an increased or equivalent benefit and when there is a decrease in benefit along with a decreased or equivalent risk when comparing a new device to a predicate device.