Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. 24
Washington Marriott at Metro Center
Completing the MTLI set of interactive submissions workshops, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs will 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 the FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies, and the care and feeding of approved PMAs. Visit MTLI online for more information.
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