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. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering an FDA series. This second session will focus on research involving medical devices and the special considerations associated with obtaining IRB approval. By the end of the session, participants will be able to:
• Explain common regulatory terms in the context of FDA-regulated device studies
• Differentiate between clinical investigations requiring Investigational Device Exemptions (IDEs), Nonsignificant Risk (NSR) device investigations, and IDE-exempt investigations
• Identify and complete Buck-IRB application sections and documents required for medical device research
• Recognize how and when to consult the FDA
Please note, this intermediate-level webinar assumes a basic familiarity with the IRB approval process and Buck-IRB, and will not cover emergency use, expanded access, or Humanitarian Use Device (HUD) protocols. While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome.
Attendance at this event is approved for 2.00 contact hours each of clinical
research-related education on applications for Maintenance of ACRP’s CCRC®,
CCRA®, CPI® or ACRP-CP® certification designations.