FDA Holds Public Hearing and Seeks Comment on Draft Guidances Concerning Regulation of HCT/Ps
Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps). 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.