The U.S. Food and Drug Administration (FDA) is issuing this message to provide clarification on importing biological specimens (e.g. urine, stool, tissue affixed to a slide, blood, plasma, serum, biopsies) for testing in a clinical laboratory or for basic scientific research.
If the biological specimens being imported are intended 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, or conditions in human beings, then the specimens are not considered to be biological products subject to licensure by FDA, nor would they appear to be a drug or device.
As such, biological specimens intended for testing in a clinical laboratory or for basic scientific research are not regulated by FDA and should be disclaimed. FDA recommends that importers clearly indicate the shipment contents and intended use on any associated documentation/labeling.
However, if the biological specimens are intended for processing or manufacturing HCT/Ps or biological products, drugs, or devices, then the products are subject to FDA jurisdiction and must meet FDA's requirements for HCT/Ps, biological products, drugs, and/or devices.
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