[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.41]

[Page 69]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 7_ENFORCEMENT POLICY--Table of Contents
 
 Subpart C_Recalls (Including Product Corrections)_Guidance on Policy, 
                Procedures, and Industry Responsibilities
 
Sec.  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.