Background

The Food and Drug Administration has issued a final rule that, effective Nov. 17, will require the following data elements to be submitted in the Automated Commercial Environment at the time of entry for veterinary devices being imported or offered for import.

- FDA country of production

- complete FDA product code

- full intended use code

- phone number and email address of the importer of record

These data elements are already required to be submitted for the electronic filing of entries containing food contact substances, drugs, biological products, human cells, tissues or cellular or tissue-based products, medical devices for human use, radiation-emitting electronic products, cosmetics, and tobacco products
The FDA anticipates that this change will streamline its import admissibility process by facilitating automated “may proceed” determinations for those veterinary devices that present a low risk to public health.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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