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FDA’s “Same Surgical Procedure” Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies


Executive Summary - June 2015

FDA’s “Same Surgical Procedure” Draft Guidance Could Stifle Use of Autologous Stem Cell Therapies
Areta Kupchyk (Nixon Peabody LLP, Washington, DC)

Although human cells, tissues, and cellular and tissue-based products (HCT/Ps) are subject to U.S. Food and Drug Administration (FDA) regulations, the use of HCT/Ps, including autologous stem cell therapies, would be exempt from FDA oversight as long as the removal and re-implantation into the same patient occur in the “same surgical procedure.” FDA’s draft guidance interpreting the meaning of same surgical procedure would exclude HCT/Ps sent to another facility for processing or storage, as well as HCT/Ps subjected to centrifugation or other commonly used processing steps. Even though the draft guidance, if finalized as written, could impact the practice of medicine using HCT/Ps, particularly autologous stem cells, few people have commented. Of those comments submitted, practitioners and patients uniformly opposed the draft guidance, while no comments supported it. The comment period formally closed at the end of December 2014; nevertheless, public comments may be submitted on guidance documents at any time. FDA is not required to consider late-filed comments; however, FDA has no deadline to act. Additional comments submitted before FDA begins finalizing the guidance could be influential.

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