Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.
The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.
D001688:Biological Products / Q000592:standards*; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D018929:Cell Culture Techniques / Q000592:standards*; D003257:Consumer Product Safety; D003365:Costs and Cost Analysis; D018562:Disease Transmission, Infectious / Q000331:legislation & jurisprudence / Q000517:prevention & control; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D004335:Drug and Narcotic Control; D005568:Forms and Records Control / Q000592:standards; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence / Q000592:standards; D011786:Quality Control; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D046509:Tissue Culture Techniques / Q000592:standards*; D016378:Tissue Transplantation; D014184:Transplantation, Homologous; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products