Some studies are exempt from most of 21 CFR Part 812 because of the low risk they pose to study subjects. However, studies that will support a PMA or other premarket submission should have the same goals as all other device studies:
- to produce valid scientific evidence to support reasonable assurance of a product’s safety and effectiveness, and
- to protect study subjects. Therefore, the information in 21 CFR Part 812 will also be useful to sponsors and investigators of device studies exempt under 21 CFR 812.2(c). In addition, all studies that will support applications to FDA are subject to 21 CFR 812.119(c) as well as to 21 CFR Parts 50 and 56.
