Does FDA regulate human tissue intended only for educational use or for basic scientific research?
No. If the human tissues you are offering for import are intended for use only for educational use or for basic scientific research and are not intended for implantation, transplantation, infusion, or transfer into a human recipient, the tissues are not subject to FDA’s human tissue regulations or FDA import review. If your broker needs to “disclaim” FDA jurisdiction, please see (link to “How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research?” I want to import an unlicensed antivenin? What steps should I take? The steps to take to import an unlicensed antivenin into the United States are explained at Information on the Use of Antivenoms (See Related Information).
Related Questions
- I want to import human tissues for educational use or for basic scientific research. Does FDA regulate human tissue intended only for educational use or for basic scientific research?
- Im new to MatTeks in vitro human tissue technology– do you have some basic information on these products?
- Does FDA regulate human tissue intended only for educational use or for basic scientific research?
