The U.S. Food and Drug Administration (FDA) released draft guidance titled Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271. The draft guidance is applicable to a wide range of non-reproductive HCT/Ps “containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” HCT/Ps excluded from the guidance include reproductive HCT/Ps; whole human organs; certain whole blood, blood components or blood derivative products subject to listing under 21 C.F.R. parts 207 and 607; secreted or extracted human products; minimally manipulated bone marrow HCT/Ps derived from animals; and in vitro diagnostic products.  When finalized, the draft guidance will supplement section XXII of the Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (December 2011) and replace Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (November 2005).  Comments to the draft guidance should be submitted by April 21, 2015 for FDA consideration.

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