Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel

17 November 2011, Wilmington, United States

Introduction

: This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA.