Fda Submission Guide

FDA Submission Guide

FDA Medical Device Classification and Pathways

Class I Devices

• 510(k) Exempt - Most Class I devices
• General Controls apply (21 CFR 820)
• FDA registration required
• Device listing mandatory

Class II Devices

• 510(k) Clearance - Premarket notification
• General + Special Controls apply
• Predicate device identification required
• Substantial equivalence demonstration