FDA Regulatory Approach to Reproductive Tissues
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.
- 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
- 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
- 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.U.S. Food and Drug Administration. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073964.htm. Accessed 18 Jun 2012.
- 27.U.S. Food and Drug Administration. Guidance for industry: compliance with 21 CFR part 1271.150(c)(1) – manufacturing arrangements. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm073991.htm. Accessed 18 Jun 2012.
- 28.U.S. Food and Drug Administration. Regulations of tissues, exemptions and alternative procedures. http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ExemptionsandAlternativeProcedures/default.htm. Accessed 18 Jun 2012.
- 29.U.S. Food and Drug Administration. Compliance program 7341.002A- inspection of tissue establishments. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/ucm095218.htm. Accessed 18 Jun 2012.