Office of Regulatory Affairs and Quality IDE Workshop (November 20, 2019)
The aim of this workshop is to educate clinical researchers on the regulatory requirements for clinical studies of medical devices that require an Investigational Device Exemption (IDE) application, and to help the audience understand when those regulations apply. The workshop will cover FDA meetings, IDE content, IDE submission and review, IDE maintenance, and the use of expanded access IDEs. The goal of this workshop is to support a better understanding of FDA regulations that will lead to better compliance with those regulations.
Clinical research professionals, including physician investigators, regulatory professionals, study coordinators, and research nurses..
Provide an overview of when and how the IDE regulations apply to clinical trials.
- 2.75 AMA PRA Category 1 Credit(s)™
- 2.75 ANCC
- 2.75 Attendance