Vice President, Global Regulatory Policy Medtronic
This session will introduce the ASCA Pilot, a new, voluntary initiative designed to enhance FDA's approach to conformity assessment in premarket review. The Pilot is expected to increase FDA's confidence in test methods and results from ASCA-accredited testing laboratories in device submissions, which means that manufacturers should generally see fewer requests for additional information regarding testing methods. This, in turn, helps lead to a more consistent, efficient and least burdensome approach to device review. This session will explain the benefits of the Pilot and offer instructions on how manufacturers can effectively participate. This includes the appropriate use of FDA-recognized consensus standards and declarations of conformity, as well as a step-by-step tutorial on how to compile an ASCA submission.