FDA 21 CFR 1271

The FDA 21 Code of Federal Regulations 1271 regulates the use of Human Cell, Tissues, and Cellular and Tissue based Products (HCT/P). 1271.10 outlines specific requirements for HCT/Ps to be regulated under section 361 of the Public Health Services (PHS) Act. HCT/Ps falling under section 361 are not regulated by the FDA.

FDA 21 CFR 1271.15 identifies exceptions to the guidelines outlined in 1271.10.

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