FDA Regulatory Approach to Reproductive Tissues

  • Karoll J. Cortez
  • Ellen Lazarus
  • Melissa A. Greenwald


FDA regulations related to reproductive tissue donation are designed to reduce the risk of communicable disease transmission. The goal of this chapter is to provide a broad overview of how FDA regulates donated reproductive tissues used for assisted reproductive technologies (ART) that will be useful for clinicians and laboratories providing these medical services and treatments. This chapter relies on FDA regulations and FDA guidance documents. It is recommended to refer to the regulations themselves, and the guidance documents and other references, for complete information about the regulatory requirements.


Intimate Partner Assisted Reproductive Technology Communicable Disease Reproductive Tissue Donor Screening 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Eastlund T. Infectious disease transmission through cell, tissue, and organ transplantation: reducing the risk through donor selection. Cell Transplant. 1995;4(5): 455–77.PubMedCrossRefGoogle Scholar
  2. 2.
    Pels E, Vrensen GF. Microbial decontamination of human donor eyes with povidone-iodine: penetration, toxicity, and effectiveness. Br J Ophthalmol. 1999;83(9):1019–26.PubMedCrossRefGoogle Scholar
  3. 3.
    Tugwell BD, Patel PR, Williams IT, et al. Transmission of hepatitis C virus to several organ and tissue recipients from an antibody-negative donor. Ann Intern Med. 2005;143(9):648–54.PubMedGoogle Scholar
  4. 4.
    Lee EH, Ferguson D, Jernigan D, et al. Invasive group-a streptococcal infection in an allograft recipient. A case report. J Bone Joint Surg Am. 2007;89(9): 2044–7.PubMedCrossRefGoogle Scholar
  5. 5.
    Kainer MA, Linden JV, Whaley DN, et al. Clostridium infections associated with musculoskeletal-tissue allografts. N Engl J Med. 2004;350(25):2564–71.PubMedCrossRefGoogle Scholar
  6. 6.
    Cartwright EJ, Prabhu RM, Zinderman CE, et al. Transmission of Elizabethkingia meningoseptica (formerly Chryseobacterium meningosepticum) to tissue-allograft recipients: a report of two cases. J Bone Joint Surg Am. 2010;92(6):1501–6.PubMedCrossRefGoogle Scholar
  7. 7.
    Hadchouel M, Scotto J, Huret JL, Molinie C, Villa E, Degos F, Brechot C. Presence of HBV DNA in spermatozoa: a possible vertical transmission of HBV via the germ line. J Med Virol. 1985;16:61–6.PubMedCrossRefGoogle Scholar
  8. 8.
    Davison F, Alexander GJ, Trowbridge R, Fagan EA, Williams R. Detection of hepatitis B virus DNA in spermatozoa, urine, saliva and leucocytes, of chronic HBsAg carriers. A lack of relationship with serum markers of replication. J Hepatol. 1987;4:37–44.PubMedCrossRefGoogle Scholar
  9. 9.
    Tedder RS, Zuckerman MA, Goldstone AH, Hawkins AE, Fielding A, Briggs EM, Irwin D, Blair S, Gorman AM, Patterson KG, et al. Hepatitis B transmission from contaminated cryopreservation tank. Lancet. 1995;346: 137–40.PubMedCrossRefGoogle Scholar
  10. 10.
    Zhang H, Dornadula G, Beumont M, Livornese Jr L, Van Uitert B, Henning K, Pomerantz RJ. Human immunodeficiency virus type 1 in the semen of Men receiving highly active antiretroviral therapy. N Engl J Med. 1998;339:1803–9.PubMedCrossRefGoogle Scholar
  11. 11.
    Lesourd F, Izopet J, Mervan C, Payen JL, Sandres K, Monrozies X, Parinaud J. Transmissions of hepatitis C virus during the ancillary procedures for assisted conception. Hum Reprod. 2000;15:1083–5.PubMedCrossRefGoogle Scholar
  12. 12.
    Levy R, Tardy JC, Bourlet T, Cordonier H, Mion F, Lornage J, Guerin JF. Transmission risk of hepatitis C virus in assisted reproductive techniques. Hum Reprod. 2000;15:810–6.PubMedCrossRefGoogle Scholar
  13. 13.
    Levy R, Bourlet T, Maertens A, Salle B, Lornage J, Laurent JL, Pozzetto B, Guerin JF. Pregnancy after safe IVF with hepatitis C virus RNA-positive sperm. Hum Reprod. 2002;17:2650–3.PubMedCrossRefGoogle Scholar
  14. 14.
    Meseguer M, Garrido N, Gimeno C, Remohí J, Simón C, Pellicer A. Comparison of polymerase chain reaction-dependent methods for determining the presence of human immunodeficiency virus and hepatitis C virus in washed sperm. Fertil Steril. 2002;78:1199–202.PubMedCrossRefGoogle Scholar
  15. 15.
    Passos EP, Silveira TR, Salazar CC, Facin AC, Souza CA, Guerin YL, Gratão AA, Cunha-Filho JS. Hepatitis C virus infection and assisted reproduction. Hum Reprod. 2002;17:2085–8.PubMedCrossRefGoogle Scholar
  16. 16.
    Huang JM, Huang TH, Qiu HY, Fang XW, Zhuang TG, Qiu JW. Studies on the integration of hepatitis B virus DNA sequence in human sperm chromosomes. Asian J Androl. 2002;4:209–12.PubMedGoogle Scholar
  17. 17.
    Leruez-Ville M, de Almeida M, Tachet A, Dulioust E, Guibert J, Mandelbrot L, Salmon D, Jouannet P, Rouzioux C. Assisted reproduction in HIV-1-serodifferent couples: the need for viral validation of processed semen. AIDS. 2002;16:2267–73.PubMedCrossRefGoogle Scholar
  18. 18.
    Pasquier C, Bujan L, Daudin M, Righi L, Berges L, Thauvin L, Berrebi A, Massip P, Puel J, Izopet J. Intermittent detection of hepatitis C virus (HCV) in semen from Men with human immunodeficiency virus type 1 (HIV-1) and HCV. J Med Virol. 2003;69:344–9.PubMedCrossRefGoogle Scholar
  19. 19.
    Wang S, Peng G, Li M, Xiao H, Jiang P, Zeng N, Wang Z. Identification of hepatitis B virus vertical transmission from father to fetus by direct sequencing. Southeast Asian J Trop Med Public Health. 2003;34:106–13.PubMedGoogle Scholar
  20. 20.
    Bourlet T, Levy R, Laporte S, Blachier S, Bocket L, Cassuto G, Chollet L, Leruez-Ville M, Maertens A, Mousnier F, Pasquier C, Payan C, Pellegrin B, Schvoerer E, Zavadzki P, Chouteau J, Duverlie G, Izopet J, Lunel-Fabiani F, Pawlotsky JM, Profizi N, Rouzioux C, Stoll-Keller F, Thibault V, Wattré P, Pozzetto B. Multicenter quality control for the detection of hepatitis C virus RNA in seminal plasma specimens. J Clin Microbiol. 2003;41:789–93.PubMedCrossRefGoogle Scholar
  21. 21.
    Huang JM, Huang TH, Qiu HY, Fang XW, Zhuang TG, Liu HX, Wang YH, Deng LZ, Qiu JW. Effects of hepatitis B virus infection on human sperm chromosomes. World J Gastroenterol. 2003;9:736–40.PubMedGoogle Scholar
  22. 22.
    Letur-Könirsch H, Collin G, Sifer C, Devaux A, Kuttenn F, Madelenat P, Brun-Vezinet F, Feldmann G, Benifla JL. Safety of cryopreservation straws for human gametes or embryos: a study with human immunodeficiency virus-1 under cryopreservation conditions. Hum Reprod. 2003;18:140–4.PubMedCrossRefGoogle Scholar
  23. 23.
    Papaxanthos-Roche A, Trimoulet P, Commenges-Ducos M, Hocké C, Fleury HJ, Mayer G. PCR-detected hepatitis C virus RNA associated with human zona-intact oocytes collected from infected women for ART. Hum Reprod. 2004;19:1170–5.PubMedCrossRefGoogle Scholar
  24. 24.
    Maertens A, Bourlet T, Plotton N, Pozzetto B, Levy R, Maertens A, et al. Validation of safety procedures for the cryopreservation of semen contaminated with hepatitis C virus in assisted reproductive technology. Hum Reprod. 2004;19:1554–7.PubMedCrossRefGoogle Scholar
  25. 25.
    Title 21 Code of Federal Regulations Part 1270 Human Tissue Intended for Transplantation Source: 62 Fed. Reg. 40444, 29 Jul 1997.Google Scholar
  26. 26.
    U.S. Food and Drug Administration. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Accessed 18 Jun 2012.
  27. 27.
    U.S. Food and Drug Administration. Guidance for industry: compliance with 21 CFR part 1271.150(c)(1) – manufacturing arrangements. Accessed 18 Jun 2012.
  28. 28.
    U.S. Food and Drug Administration. Regulations of tissues, exemptions and alternative procedures. Accessed 18 Jun 2012.
  29. 29.
    U.S. Food and Drug Administration. Compliance program 7341.002A- inspection of tissue establishments. Accessed 18 Jun 2012.

Copyright information

© Springer-Verlag London 2013

Authors and Affiliations

  • Karoll J. Cortez
    • 1
  • Ellen Lazarus
    • 2
  • Melissa A. Greenwald
    • 1
  1. 1.Human Tissue and Reproduction Branch, Division of Human Tissues, Office of Cellular, Tissue and Gene TherapiesCenter for Biologics Evaluation and Research, Food and Drug AdministrationRockvilleUSA
  2. 2.Division of Human Tissues, Office of Cellular, Tissue and Gene TherapiesCenter for Biologics Evaluation and Research, Food and Drug AdministrationRockvilleUSA

Personalised recommendations