Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics Guidance for Industry and Food and Drug Administration Staff September 2018

GUIDANCE DOCUMENT

• Docket Number: FDA-2014-D-0900
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

A submitter of a premarket notification submission (510(k)) must demonstrate to the Food and Drug Administration (FDA) that the “new device” is “substantially equivalent” (SE) to a legally marketed predicate device. This guidance is intended to help 510(k) submitters demonstrate substantial equivalence. This guidance does not add new regulatory requirements for submitters, it does not change the 510(k) premarket review standard nor does it create extra or new burdens on what has traditionally been submitted in 510(k)s. FDA developed this guidance to improve the predictability, consistency, and transparency of the 510(k) premarket review process. Furthermore, this document is intended to serve as an aid for evaluating the benefit-risk profile of a new device in comparison to the predicate device.

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