What standards apply to imports that are regulated by the Center for Biologics Evaluation and Research (CBER)?
CBER regulates biological and related products, including blood and blood products (which includes certain kinds of devices), vaccines, allergenics, tissues, and cellular and gene therapies. CBER also regulates the medical devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products and all HIV test kits used both to screen donor blood, blood components, and cellular products and to diagnose, treat, and monitor persons with HIV and AIDs. In order to import a CBER-regulated product into the United States, the product must meet FDA’s regulatory requirements. Foreign firms which manufacture products regulated by CBER that are directly or indirectly imported into the United States must comply with applicable FDA requirements before, during, and after importing into the United States. FDA does not recognize regulatory approvals from other countries. General information about CBER is available at http://www.
