How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research?
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 i
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