Importing Biological Specimens for Clinical Testing or Research Use Only
Frequently Asked Questions (FAQs)
I want to import biological specimens (e.g. blood, tissue, DNA) for testing in a clinical laboratory or for basic scientific research. Does the FDA regulate biological specimens intended only for testing in a clinical laboratory or use for basic scientific research?
No. If the biological specimens you are offering for import are intended for use only for testing in a clinical laboratory or for basic scientific research and are not articles intended for the prevention, treatment, diagnosis, or cure of diseases, injuries, or conditions in human beings, the specimens are not considered to be biological products subject to licensure by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they appear to be a drug or device as defined in sections 201(g) and (h), respectively, of the Food, Drug, and Cosmetic Act [21 USC 321(g) and (h)], nor an HCT/P as defined in 21 CFR 1271.3, which was promulgated under Section 361 of the PHS Act [42 USC 264].
What is the importing process?
The U.S. Customs and Border Protection (CBP) has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing U.S. trade laws. Information must be filed with CBP for all goods imported or offered for importation into the United States. This information, presented in an "entry notice," must be filed with CBP by the importer of record. Frequently, a Customs broker files entry on behalf of the importer of record. The person presenting entry information to CBP is known as the "filer."
When submitting an entry notification, a filer will determine the appropriate tariff code for the product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of "disclaiming" FDA jurisdiction. This is accomplished by disclaiming the "line" in the entry that applies to those products.
Tariff codes that cover both FDA and non-FDA regulated products have an "Other Government Agency (OGA)" flag which would allow the filer to disclaim FDA jurisdiction. If the tariff code you or your filer are using for your specimens does not have an OGA flag that will allow the filer to "disclaim" the line(s) in the entry, the filer should contact FDA's Division of Import Operations & Policy at 301-443-6553 to determine if the OGA flag for the tariff code can be modified to allow use of the disclaim process.
What are my responsibilities as an importer of such biological specimens?
As explained above, if your biological specimens are intended for testing in a clinical laboratory or for basic scientific research, the product is not regulated by FDA. Thus, when submitting the entry notification for the specimens, the filer should disclaim that line. Note that if the person to whom the product is shipped (the consignee) is not using the samples for testing, but instead is processing or manufacturing HCT/Ps or biological products, drugs, or devices with these biological specimens, then the products are subject to FDA jurisdiction and must meet FDA's requirements for HCT/Ps, biological products, drugs, and/or devices.
In addition, to avoid possible delays with importation of specimens for testing or research, it is recommended that the labeling of each specimen container include the following information to make clear that the specimens do not fall under FDA regulation:
- An accurate description of the biological specimens. For example: human blood specimen, human tissue specimen, human DNA specimen.
- A statement regarding the intended use of the specimen. For example: "Human Blood For Testing in a Clinical Laboratory," or "Human DNA Specimen for Basic Scientific Research."
- If the biological specimen has been tested for infectious agents such as the hepatitis B surface antigen (HBsAg) and/or the antibody to human immunodeficiency virus (anti-HIV), a statement relative to the test results should be included.
Are there any other federal agencies that may have requirements?
Yes. The Centers for Disease Control and Prevention (CDC); the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS); and the US Customs and Border Protection have regulations that may also apply to biological specimens.
If the material is suspected or known to contain etiologic agents or has not been tested for etiologic agents, a CDC Etiologic Agent Import Permit (see http://www.cdc.gov/od/ohs/biosfty/imprtper.htm) may be required. CDC can be contacted at:
Centers for Disease Control and Prevention
Office of Health and Safety FO5
Atlanta, Georgia 30333
Phone: (404) 639-3311 or (404) 498-2260
Website: www.cdc.gov/od/ohs
The U. S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), regulates the import of all animal-origin materials that could represent a disease risk to U.S. livestock and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and by products, but biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures). USDA/APHIS can be contacted at:
USDA, APHIS, VS
National Center for Import and Export
4700 River Rd. Unit 39
Riverdale, MD 20737
Phone: (301) 734-3277
Website: www.aphis.usda.gov/vs/ncie/
The US Customs and Border Protection (CBP) has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing U.S. trade laws. All goods imported or offered for importation into the United States must first pass through CBP control. CBP can be contacted at:
US Customs and Border Protecti
(202) 344-2050
1300 Pennsylvania Avenue, N.W.
Washington, D.C. 20229
http://www.customs.gov/