There are many articles falling under the definition of a device in Section 201(h) of the FD&C Act which are intended for animal use which are parallel in intent and function to devices intended for human use. There are, however, a number of articles which are peculiar to animal use and have no parallel human use. Devices intended for animal use require no pre-marketing clearance. They may, however, be deemed to be adulterated or misbranded under the general provisions of 501 and 502 as may be determined by the *Center for* Veterinary Medicine.
Articles intended for use in animals which conform to the definition of a device under 201(h) and which are suspected as being hazardous or otherwise adulterated or misbranded may be submitted to the *Center for* Veterinary Medicine (HFV-236) with recommendations for regulatory action.
*Material between asterisks is new or revised*