Table 1.

Primary FDA Governing Documents For Human Cell Therapies and Products (HCT/Ps)^a

FDA Document	Year	Key Features
Federal Food, Drug, and Cosmetic Act43	1993	Categorized HCT/Ps as drugs or devices, bringing them under the FDA’s regulation
Public Health Service Act, Section 35144	1998	Established and regulates a category of biological products
Public Health Service Act, Section 36145	1998	Regulations to control the spread of communicable disease, including the purity and release criteria for HCT/Ps
Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)	2009	Established manufacturing standards for human cells, tissues, and HCT/Ps
21st Century Cures Act40	2016	Established new mechanisms for review, alternative approval endpoints, and increased funding for regenerative medicine research
Same Surgical Procedure Exemption under 21 CFR1271.15(b)46	2017	Describes what procedures qualify as “same” and what can be done to process HCT/Ps prior to reutilization
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue based products13	2017	Defines “minimal manipulation” and “homologous use”, how to apply these definitions to HCT/Ps, and describes how the FDA will enforce these definitions
Evaluation of Devices used with Regenerative Medicine Advanced Therapies41	2017	Details how the FDA will handle devices used in Regenerative Medicine Advanced Therapies (RMATs)
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions42	2017	Describes the new RMAT designation and additional effort to increase communication and collaboration between the FDA and investigators

^aAbbreviations: CGTP, current good tissue practice; HCT/Ps, human cell therapies and products; RMATs, regenerative medicine advanced therapies