The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s Elias Mallis discusses the purpose of the DRAFT guidance document titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s.” This guidance document serves to provide clarity, transparency, consistency, and predictability in the 510(k) decision-making process. It addresses each of the critical decision points in the substantial equivalence evaluation of a 510(k), and addresses elements identified in the 510(k) Implementation Plan that was issued by CDRH in January 2011. (Javascript is required to view Mediasite content)