What role does FDA play when an FDA-regulated article is offered for import?
If the article being imported falls under FDA’s jurisdiction, it is subject to FDA review. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) sets out basic standards and procedures for FDA review of imports under its jurisdiction. Section 801(a) provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements. FDA regulations at 21 CFR 1271.420 set out the basic import standards and procedures for human tissues. As explained in more detail below, FDA and CBP have coordinated their efforts and work together to ensure the smooth processing of FDA-regulated imports.
If the article being imported falls under FDA’s jurisdiction, it is subject to FDA review. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) sets out basic standards and procedures for FDA review of imports under its jurisdiction. Section 801(a) provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements. FDA regulations at 21 CFR 1271.420 set out the basic import standards and procedures for human tissues. As explained in more detail below, FDA and CBP have coordinated their efforts and work together to ensure the smooth processing of FDA-regulated imports.
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