[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.
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