Medical devices containing animal derived ingredients that have been approved by the Food and Drug Administration now may enter the US without the need for an import permit from USDA’s Animal and Plant Health Inspection Service. In a stakeholder import alert issued recently, APHIS announced that it had determined, in consultation with FDA, that these devices present negligible risk for introducing foreign animal disease into the US.
Specifically, an APHIS import permit (VS Form 16-6) no longer will be required for FDA-approved human medical devices containing animal origin ingredients when the devices are in final dosage form and ready for use. In order for these products to be imported without an import permit, it will need to be accompanied by a written statement supplied on foreign producer/shipper letterhead confirming that the imported product is approved by FDA; and a copy of the FDA-approved commercial product label.
In order to facilitate correct identification of the shipment and to ensure timely delivery, APHIS advised in its import alert that the documentation should accompany each shipment and be presented for review by the Department of Homeland Security, Customs and Border Protection, and Agriculture Specialists/Officers at the US port of arrival.
Regulations mandate that no organisms or vectors shall be imported into the US, or transported from one state to another, without a permit. The Organisms and Vectors unit of the Agriculture Select Agent Services staff within APHIS regulates the importation and transportation of materials derived from animals or exposed to animal-source materials, including pathogen organisms and vectors, and issues the permits (VS Form 16-6) to the recipient.
According to an APHIS fact sheet, a USDA veterinary permit is needed for materials derived from animals or exposed to animal-source materials. Materials which require a permit include animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi.
Controlled materials that require a permit include, but are not limited to, microorganisms that are pathogenic to livestock or poultry, their extracted nucleic acids, inactivated and killed products, and vectors of livestock or poultry pathogens. Some examples or organisms and vectors that require VS permit for import or interstate transportation include:
- Pathogens that can initiate or disseminate disease in livestock and poultry;
- Vectors that can serve as the carrier of or have been exposed to an infectious disease of livestock or poultry;
- Animal specimens including tissue, fluids, or blood collected from animals infected with pathogens or exposed to pathogens or vectors;
- Cell cultures exposed to organisms that cause disease in livestock or poultry;
- Human viruses and human vaccines intended for research use in livestock or poultry;
- Attenuated live viruses and vaccine strains; and
- Fish pathogens: infectious salmon anemia virus, spring viremia of carp virus, and viral hemorrhagic septicemia virus.
There are certain exceptions to this requirement for human and non-human primate tissues, serum, and blood, as well as a limited list of other products.
For recipients of materials derived from animals or exposed to animal-source materials, including the organisms and vectors listed above, to obtain a VS Form 16-6 permit, they are required to submit a VS Form 16-3 application. Note that VS Form 16-3 is not a permit, but merely the application form, while VS Form 16-6A is the actual permit that is issued by APHIS, and it commonly is referred to as VS Form 16-6.