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:
- Strategic considerations to weigh when leveraging foreign clinical data;
- Good Clinical Practice (GCP) requirements;
- Valid and scientific evidence; and
- Risk mitigation activities pertaining to Bioresearch Monitoring (BIMO) audits.
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.