510(k) Submissions - The Course for Beginning RA Professionals for Preparing a 510(k)

February 22 – 23, 2010 — The Westin Casuarina Hotel, Las Vegas, NV

This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps, and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with FDA during the review process, and dealing with post-clearance issues.