FDA Guidance for Industry

Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement 

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

Food and Drug Administration

21 CFR Parts 16, 1270, and 1271

[Docket No. 1997N–484P]

AGENCY: Food and Drug Administration, HHS.

ACTION: 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.

DATES: This rule is effective May 25, 2005.

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Last Updated: 2015-08-04