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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Last week, FDA held a two-day public hearing to obtain input on its four draft guidance documents concerning human cells, tissues, and cellular and tissue-based products (HCT/Ps).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.

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About this Author

Julia Post, Food and drug attorney, Covington
Associate

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Ms. Post has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Ms. Post was a member of...

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