Establishment registration and listing for manufacturers of human cellular and tissue-based products--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to require manufacturers of certain human cellular and tissue-based products to register with the agency and list their products. In addition, the agency is proposing to amend the registration and listing regulations that currently apply to human cellular and tissue-based products regulated as drugs, devices, and/or biological products. This action is being taken to establish a unified registration and listing program for human cellular and tissue-based products.
D017690:Cell Transplantation / Q000592:standards*; D003140:Communicable Disease Control; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D011786:Quality Control; D014183:Transplantation, Heterologous / Q000592:standards*; D014184:Transplantation, Homologous / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration