title: Human cells, tissues, and cellular and tissue-based products; establishment registration and listing.  Food and Drug Administration, HHS.  Final rule.
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.
mesh_terms: D001685:Biological Factors / Q000592:standards; D001709:Biotechnology / Q000331:legislation & jurisprudence*; D002477:Cells; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence / Q000592:standards; D011786:Quality Control; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001685:Biological Factors