Most manufacturers of Class I and Class II medical devices seek to avoid the FDA’s premarket approval (PMA) pathway at all costs, opting instead for the kinder, gentler, and faster 510(k) route. But is that the right approach for your device? Believe it or not, the dreaded PMA can actually be your ally in regulatory strategy, helping make it more difficult for your competitors to bring similar products to market. In this podcast, Med Device Online’s Jim Pomager talks with Vascular Sciences’ Mike Drues about the ways in which the PMA path can actually benefit device makers — and about recent FDA guidance that could make the PMA less ominous.
**For those of you interested in further information about the PMA pathway, Dr. Drues will be teaching an online course entitled The Premarket Approval Pathway: Ensure Successful Regulatory Submissions. The 90-minute course will be presented by Life Science Training Institute on June 4, 2014, at 1 pm EDT time. For more information or to register, visit here.