FDA-regulated Research: Myth vs. Reality - Part 2: Medical Devices

Although OHRP and FDA regulations are similar, differences exist based on FDA’s unique scope and requirements. These sessions focus on research involving medical devices and the special considerations associated with obtaining IRB approval.

Session 1

The first recording explains common regulatory terms in the context of FDA-regulated medical device studies, differentiates between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk device investigations, and IDE-exempt investigations, and how and when to consult the FDA.

• Watch the FDA-regulated Research: Myth vs. Reality – Part 1: Medical Devices Video
• PowerPoint presentation
• FDA device resources

Session 2

The second session covered applying regulatory information from the pre-recorded session to real-life examples of medical device research, using tools to determine which of the five most common device research scenarios applies to your research, identifying supporting documents required for medical device research and completing Buck-IRB application sections required for FDA-regulated medical device research.

• Watch the FDA-regulated Research: Myth vs. Reality – Part 2: Medical Devices Video
• PowerPoint presentation
• FDA-Regulated Medical Device Studies Tools for Investigators
• FDA-regulated Medical Devices Group Activities