PMA Submissions Workshop

February 25 – 26, 2010 — The Westin Casuarina Hotel, Las Vegas, NV

Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs.