Medical device trials operate under a different set of rules, risks, and realities compared to drug trials, and every clinical research professional should understand those differences. This session begins with a 10-minute foundational overview of how devices are classified and regulated, then transitions into 40 minutes of deeper insights into study design, risk determination, IDE submissions, and operational considerations unique to device trials. Attendees will leave better equipped to navigate the complexities of device research with confidence and clarity.

Learning Objectives:

1. Differentiate medical device trials from drug trials in terms of regulatory frameworks, classification, and approval pathways.
2. Describe the key components of device study design, including risk assessment, data collection, and endpoint selection.
3. Identify operational and compliance challenges specific to device trials, including IDE requirements, site training, and safety reporting.