Question

The QSR for Class III devices applies to the following except:

A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in the United States
C) Research on investigational devices tested outside of the United States
D) Contract Sterilizers

Answer 1

The QSR for Class III devices applies to critical component manufacturers, operations done by the manufacturer at facilities located in the United States, and contract sterilizers. However, it does not apply to research conducted on investigational devices tested outside of the United States. Correct option is C.

Step-by-step explanation:

The QSR (Quality System Regulation) for Class III devices applies to critical component manufacturers, operations done by the manufacturer at facilities located in the United States, and contract sterilizers. However, it does not apply to research conducted on investigational devices tested outside of the United States. This means that option C, research on investigational devices tested outside of the United States, is the correct answer.