Articles, containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion or transfer into a human recipient, as defined by FDA in Title 21 of the Code of the Federal Regulations 22 (CFR) Part 1271, specifically 21 CFR 1271.3(d). The Agency regulates HCT/Ps with a tiered, risk- based approach designed to provide the appropriate level of oversight to protect the public health.
Menu