FDA Updates Biological Product Deviation Reporting and Product Codes for Fiscal Year 2027
The Food and Drug Administration (FDA) has updated its biological product deviation reporting and product code lists for fiscal year 2027, which officially began on October 1, 2026. The agency made no changes to the deviation codes for traditional blood and plasma establishments, licensed non-blood facilities, and human cells, tissues, and cellular and tissue-based products (HCT/Ps), according to the source article.
Reporting Requirements for Blood and Plasma Facilities
Blood and plasma establishments must continue using established agency guidelines to determine whether specific manufacturing events meet the threshold for mandatory reporting. Facilities handling blood and blood components should consult the specific guidance document titled Biological Product Deviation Reporting for Blood and Plasma Establishments. Manufacturers producing biological products outside of traditional blood components must refer instead to Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components. Alongside these operational rules, the updated blood product code list introduces one new entry: freeze-dried plasma, designated as DC46.
Expanded Product Codes Across Non-Blood Categories
The FY 2027 non-blood product-code list introduces significant category updates spanning therapeutics, gene therapies, HCT/Ps, and in vitro diagnostics. Gene therapy product listings expand to include lunsotogene parvec-cwha (TV25), marnetegragene autotemcel (TV26), etuvetidigene autotemcel (TV27), onasemnogene abeparvovec-brve (TV28), prademagene zamikeracel (TV29), and revakinagene taroretcel-lwey (TV30).
HCT/P additions incorporate HPC, Cord Blood (MH08), acellular tissue engineered vessel-tyod (MH09), donislecel (TA15), allogeneic regulatory T-cell immunotherapy with HSPC and T cells-vldq (TA16), acellular nerve allograft-arwx (TA17), and zopapogene imadenovec-drba (TA18). The in vitro diagnostics category adds the Procleix Plasmodium assay under code FY93. Regulated entities requiring clarification regarding these updates can direct inquiries to the AABB Department of Regulatory Affairs.
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