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FDA Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
Guidance for Industry and FDA Staff
This guidance document provides information about the classification of products as human cells, tissues and cellular and tissue-based product (HCT/P's) regulated solely under section 361 of the Public Health Service Act (PHS Act). Specifically, this guidance document discusses FDA's current thinking on the meaning of the phrase "minimally manipulated" contained in 21 CFR 1271.10(a)(1), and defined ("minimal manipulation") at 21 CFR 1271.3(f), as it applies to structural tissue.

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