FREE ON-DEMAND WEBINAR
Everyone knows there are three types of Premarket Notifications a.k.a. 510(k)s – traditional, special and abbreviated – or are there?
The “new” Safety and Performance Based Pathway” is an expansion of the abbreviated 510(k) for certain “well understood” devices.
In this free in-depth webinar, presented by world-renowned regulatory expert Michael Drues, Ph.D., we will explore what some call the “new” safety and performance based 510k (sp510k).