The FDA will issue a final rule tomorrow making certain data elements required for other FDA-regulated products in 21 CFR § 1.72 also mandatory for the electronic filing of entries containing a veterinary device.
The elements include 1) FDA Country of Production; 2) complete FDA Product Code; 3) full intended use code; and 4) telephone number and email address of the importer of record. FDA noted that submission of this information through the Agency’s centralized system for all import and export transactions (known as “ACE”) will assist FDA to better make admissibility determinations for veterinary devices.
The rule is slated to become effective November 17, 2022.