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

Guidance for Industry and Food and Drug Administration Staff

Document issued on: July 28, 2014

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/ucm0801 87.htm) remain in effect.

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