Human tissues for cardiovascular surgery: regulatory requirements

  • David M. Fronk
  • J. D. Ferros


The clinical use of cardiac allografts has been a mainstay in cardiovascular surgery for the past five decades for both the repair and reconstruction of congenital and acquired defects and anomalies. In order to meet these clinical needs, the tissue processors providing these tissues must comply with evolving governmental regulations established to ensure the safety and quality of the tissue. Generically considered as tissue for transplant, the history of these tissues from a regulatory perspective is both convoluted and complex. Though there are many general commonalities in the regulatory frameworks of two of the largest clinical markets for allograft cardiovascular tissue, the United States (US) and the European Union (EU), the pathway allowing for their distribution onto these markets is distinctly different. This chapter examines the governmental regulatory requirements for processed human cardiovascular tissue, with a specific focus on the regulations of the US and the EU.


European Union Human Immunodeficiency Virus Type West Nile Virus Cardiac Allograft Tissue Directive 


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  1. 18.
    US Food and Drug Administration (2007) Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2010

Authors and Affiliations

  • David M. Fronk
    • 1
  • J. D. Ferros
  1. 1.Regulatory Affairs and QualityAssurance CryoLife, Inc. CryoLife, Inc.KennesawUSA

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