It is often straightforward to recognize FDA regulatory oversight when working on industry-sponsored studies conducted under Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. However, clinical research professionals frequently encounter uncertainty when determining whether FDA oversight applies in less obvious scenarios, including investigator-initiated, multisite, or early-phase studies. This session will present a practical framework to help participants identify and flag FDA regulatory oversight by walking through key indicators of IND/IDE applicability, common misconceptions, and critical decision points that influence regulatory classification and IRB review. The session will also explore emerging regulatory considerations related to artificial intelligence and machine learning–based products, companion diagnostics, radiation-emitting devices, and digital health technologies. Participants will leave with practical decision tools, case-based examples, and communication strategies to support confident, compliant conduct of FDA-regulated research.

CEU: 1.00 ACRP

Speaker:

• Purna Garimella, MS, CIP, RAC, Director, Human Research Protection Program, Indiana University