21 CFR 860FDAactive
Medical Device Classification Procedures
Plain English Summary
Classifies medical devices into three risk categories with increasing regulatory requirements for each class.
CFR Title
21
CFR Part
860
Effective Date
May 28, 1976
Jurisdiction
US
Full Text
Medical devices are classified into three classes based on the level of control necessary to assure safety and effectiveness. Class I devices are subject to general controls; Class II devices require special controls such as performance standards; Class III devices must undergo premarket approval demonstrating safety and effectiveness.
Manufacturers must register their establishments, list their devices, and comply with quality system regulation requirements. Device reports must be submitted for deaths, serious injuries, or malfunctions.
healthcaretechnology