As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”),1 FDA committed to strengthen and modernize the premarket notification [510(k)] Program. FDA is issuing this guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. The intent of this guidance is to clarify and provide additional context for situations when clinical data may be necessary to demonstrate substantial equivalence (SE), as initially described in “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance (herein referred to as the “510(k) Program Guidance”).
In that guidance, FDA described the most common scenarios for when clinical data may be
necessary in a 510(k) submission. The scenarios are further described in this guidance, and FDA has described another scenario. In addition, FDA is providing additional examples to clarify these concepts, illustrating when clinical data may or may not be needed. Providing clarity and predictability about when clinical data may be necessary to include in a 510(k) submission to demonstrate SE will aid in protecting and promoting public health…