What are my responsibilities as an importer of such biological specimens?
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.
