Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Food and Drug Administration, HHS. Final rule.

  • 19 January 2001
    • journal article
    • Vol. 66  (13) , 5447-69
Abstract
The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products.

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