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When do I need an FDA Non-clinical Research Use Only Certificate?
The 'Non-clinical Research Use Only Certificate' is for the export of a product, material, or component, for non-clinical research use only, that is not intended for human use and which may be marketed in, and legally exported from, the United States under the Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States. (CBER and CDRH)
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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