October 05, 2026
The Food and Drug Administration recently updated its biological product deviation reporting and product code lists for fiscal year (FY) 2027, which began Oct. 1. The agency made no changes to the deviation codes for blood and plasma establishments, licensed non-blood establishments, or human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Blood and plasma establishments should refer to the guidance document, Biological Product Deviation Reporting for Blood and Plasma Establishments, to determine whether an event is reportable. Manufacturers of biological products other than blood and blood components should refer to Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components to determine whether an event is reportable.
The blood product code list adds one code, for freeze-dried plasma (DC46).
FDA’s FY2027 non-blood product-code list identifies changes in several product categories, including therapeutics, gene therapy products, HCT/Ps and in vitro diagnostics. The changes include:
Those with questions may contact AABB’s Department of Regulatory Affairs.
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