For Industry

What information do I need to import a biological product for research use only?

Biological specimens that are used only for testing in a clinical laboratory or for basic scientific research are not regulated by FDA. These are specimens that are not intended to prevent, treat, diagnose, or cure diseases, injuries, or conditions in humans, so they do not require licensure (i.e., “approval”) by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they likely be a drug or device as defined in sections 201(g) and (h), respectively, of the Federal Food, Drug, and Cosmetic Act [21 USC 321(g) and (h)], nor an HCT/P as defined in 21 CFR 1271.3, under Section 361 of the PHS Act [42 USC 264]. Detailed information about the process for importing biological products into the U.S. is available in questions and answers posted on the web.

Page Last Updated: 05/22/2016
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