RAC (Devices) Practice Questions - Regulatory Affairs Certification - Devices Exam

What is the primary purpose of an Investigational Device Exemption (IDE) under 21 CFR 812?

To allow an investigational device to be used in a clinical study to collect safety and effectiveness data To grant final marketing clearance for a Class II device To exempt a device permanently from premarket review To register the device labeler in GUDID

Correct Answer:

To allow an investigational device to be used in a clinical study to collect safety and effectiveness data

Access more questions from this quiz

Continue to RAC (Devices) Practice Questions - Regulatory Affairs Certification - Devices Exam for more practice questions and the full quiz experience.

Access More Questions