What Class I, II and III mean
Classification describes an agency assessment, not a personalized diagnosis.
Sources reviewed Oct 1, 2026. Last updated Oct 1, 2026.
Class I
FDA describes this as the most serious class: exposure may have serious health consequences. Follow the current notice and its patient or consumer instructions.
Class II and Class III
FDA associates Class II with possible temporary health consequences and a remote probability of serious harm. Class III concerns products where adverse health consequences are unlikely. Different agencies can publish different classification fields.
Missing classification
A new announcement can precede an enforcement classification. Missing or not-yet-classified information is displayed as supplied; it is not converted to Class III.