There are major differences in a SR vs. NSR studies. A SR needs to submit an IDE and must follows all regulations associated with it in 21 CFR 812. They also need that IDE approved before they can proceed with the study. However, for a NSR, the IDE application does not need to be approved by the FDA. However, it needs to follow the abbreviated requirements in 21 CFR 812.

Few examples of SR devices that we commonly know of:

Epidural and Spinal Needles
Intravascular stents
Replacement Heart valves
Pacemaker
Breast Implants
Sutures
TENS device
Intrauterine Devices (IUDs)