21 CFR 7.41 - Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being recalled or considered for recall will be conducted by an ad hoc committee of Food and Drug Administration scientists and will take into account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the use of the product.
(2) Whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard. Any conclusion shall be supported as completely as possible by scientific documentation and/or statements that the conclusion is the opinion of the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population, e.g., children, surgical patients, pets, livestock, etc., who are expected to be exposed to the product being considered, with particular attention paid to the hazard to those individuals who may be at greatest risk.
(4) Assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug Administration will assign the recall a classification, i.e., Class I, Class II, or Class III, to indicate the relative degree of health hazard of the product being recalled or considered for recall.