Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices

The Food and Drug Administration (FDA, the Agency, or we), with the Department of the Treasury's concurrence, is amending its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by U.S. Customs and Border Protection (CBP), in order for CBP to process the filing and to help FDA in determining the admissibility of those veterinary devices. This final rule will make the submission of the general data elements currently required to be submitted in ACE for other FDA-regulated products at the time of entry also required in ACE for veterinary devices being imported or offered for import into the United States. This final rule will increase effective and efficient admissibility review by FDA of those entry lines containing a veterinary device, which will protect public health by allowing the Agency to focus its limited resources on FDA-regulated products that may be associated with a greater public health risk.