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Home » Managing HCT/Ps Under the FDA's New Guidelines
Managing HCT/Ps Under the FDA's New Guidelines
January 14, 2016
Regenerative medicine is a rapidly expanding, lucrative field and continued growth is expected. Sections 351 and 361 of the Public Health Service Act (PHS Act) [42 USC 264] aim to prevent the introduction, transmission and spread of communicable diseases through the procurement, processing and use of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps) in regenerative medicine. Section 351 is the more stringent of the two because HCT/Ps that fall under that section are regulated as drugs, devices and biological products. The FDA implemented 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-based Products to define and regulate HTC/Ps in conjunction with Sections 351 and 361 of the PHS Act.