The document aims to clarify regulation rules of minimal manipulation with human cell and tissue products. The FDA’s guidance documents normally do not “establish legally enforceable responsibilities” but “describe the agency’s current thinking on a topic and should be viewed only as recommendations,” the agency said.
HCT/Ps are “intended for implantation, transplantation, infusion or transfer into a human recipient,” according to the FDA’s definition. The agency clarified that hospitals and labs do not have to register human cell and tissue-based products “that are used solely for nonclinical scientific or educational purposes.”
