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*
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.