Register for this workshop


This online session will detail information about devices and FDA regulations and when they apply.

Topics in this session include:

• Discussions regarding studying the safety and efficacy of a device
• Discussion of significant/nonsignificant risk devices
• Discussion of IDE, Abbreviated IDE, and IDE Exemption
• Use on label or off label
• Detail PI obligations should the FDA regulations apply
• IRB processes regarding medical devices and the FDA

There are no required prerequisites but completion of IRB Basics Part I is recommended.

Instructor: Jennie Ofstein