In February 2018, the U.S. Food & Drug Administration (FDA) issued a final rule on an updated regulation pertaining to the acceptance of data from clinical investigations conducted outside the United States (OUS) to support IDEs or submissions (i.e., PMAs). While it is common for medical device manufacturers to utilize OUS clinically applicable data (including clinical studies), they often require guidance regarding the advantages, disadvantages and precautions necessary to identify how to leverage data for manufacturers’ U.S. commercialization plans.
This webinar will discuss the final rule pertaining to the FDA acceptance of OUS clinical investigations and provide attendees with an understanding of:
Information from this presentation can be applied by more aptly advising manufacturers on the current regulations, advantages and disadvantages and precautions pertaining to conducting OUS studies during pre-commercial medical device development.
Time will also be allotted for Q&A.
View the recorded webinar here.
About the Presenter:
Jason Krzeszak join NAMSA in 2018 and has 15 years’ experience in medical device product development. He has led activities focused on preclinical and clinical research of devices through the feasibility, pre-market and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which also included cross-functional leadership responsibilities. HE also possesses clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in the preclinical environment.