Regulatory Definitions of Animal Use Classes | en Español
The following definitions of use classes for Major Food Animal Species, Companion Animal
Species and Minor Species have been extracted from Appendix III of
FDA Guidance for Industry
Major Food Animals
The guidance defines specific use classes of cattle, swine and poultry (chickens and turkeys)
consistent with long-standing FDA practice as well as current animal industry standards. Because
Target Animal Divisions within the
Office of New Animal Drug Evaluation (ONADE) may group or separate specific classes of species differently, you should contact the applicable Target Animal
Division to determine when separate INADs (Investigational New Animal Drug) are appropriate
for different classes or groups of classes of major food animals. For example, if a new animal drug is
being investigated for use only in specific classes within a major species of food animal, separate
INADs should be established for each species and class. If the new animal drug is being investigated
for use in all classes within a species, separate INADs for each species, but not class within species,
should be adequate. New animal drugs may be intended for intermediate groupings of cattle species due
to physiological differences, such as beef versus dairy cattle, and/or lactating versus nonlactating
cattle. Thus, for example, if a new animal drug is intended for use in beef cattle, one INAD may be
established for this group. Similarly, one INAD may be used for new animal drugs intended for use in
groupings of certain physiologically similar beef and nonlactating dairy cattle classes.
The tables below break down the classes and can be printed for reference:
Classes or breeds of companion animals generally are not distinguished in new animal drug indications.
Thus, unless a new animal drug is intended for use in a specific class (e.g., kitten versus mature cat)
or breed of companion animal, separate INADs for each species (e.g., cat, dog, horse), but not class
or breed within species, should be adequate.
In general, a separate INAD should be established for each minor species of animals being investigated
for treatment with a specific new animal drug. For aquaculture, it is recommended that separate INADs
be established for finfish, crustaceans, and mollusks. Separate life stages, including eggs, may be
included within a single INAD.