This post was written by Erin Janssen.

On December 27, 2011, FDA released draft guidance entitled “Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”  The draft guidance is designed to provide a contemporary perspective on FDA reviews of premarket notification (510(k)) submissions. The guidance addresses the major aspects of the 510(k) decision making process and updates FDA’s policies with respect to the Special and Abbreviated 510(k) programs. The intent of the draft guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence to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.  FDA is requesting comments on the guidance by April 26, 2012.