The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

FDA developed this document to provide guidance to industry and FDA staff about current review  practices for premarket notification (510(k)) submissions. The intent of this guidance is to identify,  explain, and clarify each of the critical decision points in the decision-making process FDA uses to  determine substantial equivalence. This guidance is not intended to implement significant policy  changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the  predictability, consistency, and transparency of the 510(k) program by describing in greater detail the  regulatory framework, policies, and practices underlying FDA’s 510(k) review.

The draft of this guidance document contained sections addressing FDA’s Special and Abbreviated  510(k) programs. FDA intends to finalize those sections separately. Until FDA issues new final  recommendations on the Special and Abbreviated 510(k) programs, the recommendations for Special  and Abbreviated 510(k)s contained in “The New 510(k) Paradigm – Alternate Approaches to  Demonstrating Substantial Equivalence in Premarket Notifications,” dated March 20, 1998,  (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm) remain in effect.

FDA’s guidance documents, including this guidance, do not establish legally enforceable  responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be  viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The  use of the word should in Agency guidances means that something is suggested or recommended, but not required.