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.
KeywordsIntimate Partner Assisted Reproductive Technology Communicable Disease Reproductive Tissue Donor Screening
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