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FDA Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 1/16/2009

Origin/Publisher:

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

Document Type:
Guidance for Industry
Content:
Recommendations for complying with Current Good Tissue Practice (CGTP) requirements under Title 21 Code of Federal Regulations, part 1271, subpart D (21 CFR part 1271, subpart D)1, and requirements under 21 CFR part 1271, subpart E (Additional requirements for establishments described in § 1271.10). This guidance also addresses whether the establishment registration and HCT/P listing requirements under 21 CFR part 1271, subparts A and B apply in certain instances.

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