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2022 PRIM&R Annual Conference

FDA Regulated Research

C03 - Investigational Device Exemptions (IDE) and Bioresearch Monitoring (BIMO) Inspection for Medical Device Clinical Investigations

Tuesday, December 13, 2022
11:45 AM – 12:45 PM ET
Location: Livestreamed
Livestreaming Session Icon CIP Accredited Human Subjects Research Deep Dive Series
Generally speaking, IDE regulations apply to clinical investigations of medical devices designed to determine their safety and effectiveness. What if the healthcare provider wants to use a legally marketed device? Are the requirements the same for diagnostic devices? This session will provide an overview of the IDE regulations, including applicability of the IDE regulations. In addition, it will cover the role of sponsors and investigators in device research and how BIMO inspections contribute to enter for Devices and Radiological Health's (CDRH) review process.

Learning Objectives:

  • Discuss the applicability of the IDE regulations, including significant risk vs. non-significant risk determinations
  • Review the basics of CDRH’s regulation of sponsors and investigators in clinical investigations of medical devices
  • Consider the role of BIMO inspections in the review of medical devices