FDA Regulatory Approach to Reproductive Tissues

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

Abstract

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.

Keywords

Hepatitis Assure 

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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

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