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 (GFI) 191.
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:
Companion Animals
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.
Minor Species
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.