In a Stakeholder Importer Alert dated May 31, 2018, the Animal and Plant Health Inspection Service (APHIS), advised that in consultation with the Food and Drug Administration (FDA), it has determined that FDA approved human medical devices containing animal derived ingredients present negligible risk for introducing foreign animal disease into the United States. Therefore, these commodities may now enter the United States without APHIS restrictions and an APHIS import permit (VS Form 16-6), will no longer be required when the devices are in final dosage form and ready for use (in bulk form or single packaged).

Effective May 31, 2018, FDA approved human medical devices containing animal derived ingredients may be imported without an import permit as per Guidelines for Importation of Human And Veterinary Pharmaceuticals and Vaccines, # 1100, if accompanied by a written statement supplied on foreign producer/shipper letterhead which confirms that the imported product is approved by the FDA and a copy of the FDA-approved commercial drug product label.

In order to facilitate correct identification of the shipment and to ensure timely delivery, the documentation described above should accompany each shipment and be presented for review by US Customs and Border Protection (CBP), Agriculture Specialists/Officers at the US port of arrival.