Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). Our client alert, accessed here, summarizes each of the guidance documents, highlights significant areas of discussion during the public hearing, and provides insights on potential areas for further discussion with the agency. FDA is accepting comments on the HCT/P draft guidances until September 27, 2016.
HCT/Ps are defined by FDA regulations as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient,” 21 C.F.R. § 1271.3(d), and are subject to varying levels of regulation depending on the product’s degree of risk. FDA regulates higher risk HCT/Ps as drugs, biologics, or medical devices, and such products are subject to IND/IDE requirements and the premarket review and approval/clearance requirements applicable to traditional drugs, biologics, and devices. Lower risk HCT/Ps, however, are exempt from these requirements.
Below is a list of the four draft guidances covered by the public hearing:
- Same Surgical Procedure Exception Under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception;
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products;
- Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; and
- Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.