On Monday, FDA published for public comment a proposed rule concerning the submission of certain data elements for veterinary devices imported or offered for import via the Automated Commercial Environment (ACE) or other U.S. Customs and Border Protection (CBP)-authorized electronic data interchange (EDI) system.[1] Comments are due by October 19, 2020.
The proposed rule would add veterinary medical devices to the list of other imported FDA-regulated products for which the data elements 21 C.F.R. § 1.72 requires must be submitted at the time of entry. The required data elements would include: (1) FDA Country of Production; (2) complete FDA Product Code; (3) full intended use code; and (4) importer of record telephone number and email address. FDA advises that submission of these data elements in ACE would help FDA to more effectively and efficiently make admissibility determinations for veterinary devices by increasing the opportunity in FDA’s Operational and Administrative System for Import Support (OASIS) system for automated “May Proceed” determinations for veterinary device entries. These are the same data elements that must be submitted for the electronic filing of entries containing food contact substances, drugs, biological products, HCT/Ps, medical devices for human use, radiation-emitting electronic products, cosmetics, and tobacco products.
For purposes of the proposed rule, a veterinary device is a “device” as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act that is intended for use in animals.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Animal Food and Drug practice
[1] The proposed rule can be found here.
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