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What are the FDA requirements for exporting an unapproved device?
Chapter VIII of the Federal Food, Drug, and Cosmetic Act (FD&C Act) addresses FDA regulation of the import and export of foods, drugs, cosmetics, biologics, medical devices, and radiation emitting electronic products. Sections 801 and 802 of Chapter VIII list the specific rules governing the import and export of products, including the export of unapproved products. Until April 1996 the law that governed the export of medical devices not legally marketed in the U.S. was Sections 801(e)(1) and (e)(2) of the FD&C Act. Public Law 104-134, Food and Drug Export Reform and Enhancement Act of 1996 (FDERA) modified portions of Section 801 and Section 802. This law significantly modified Chapter VIII by enhancing the ability of U.S. firms to export unapproved FDA products under certain conditions without prior permission from FDA. The most notable change was the addition of provisions to and extension of section 802 to medical devices. The basis for the regulation of imports and exports is contained in Chapter VIII of the FD&C Act. There are no regulations in the Code of Federal Regulations (CFR) that cover export requirements except for 21 CFR 812.18 regarding the export of investigational devices. Section 803 provides for the establishment of an Office of International Relations to act as FDA liaison with foreign governments. Please note that U.S. manufactures that export medical devices outside the U.S. are required to register their facility and list their devices (21 CFR 807).
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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