What is the legal status of preimplantation genetic diagnosis in the United States?
Preimplantation Genetic Diagnosis (PGD) is legal in the United States. PGD is a form of genetic testing that is conducted on embryos prior to implantation in the uterus. The purpose of this testing is to identify genetic abnormalities and to select viable embryos for in vitro fertilization (IVF). PGD can also be used to determine the sex of the embryo, which is not allowed in some states, including Indiana. In the US, PGD is regulated by the federal government’s Food and Drug Administration. In order to perform PGD, a physician must obtain an Investigational Device Exemption (IDE) from the FDA. The IDE application outlines the proposed clinical trial that the doctor will conduct. Once the IDE is approved by the FDA, the doctor can proceed with the clinical trial. In addition to the federal regulations, many states have laws that regulate how PGD is administered and used. For example, some states, like Indiana, forbid the use of PGD to determine the sex of an embryo. Other states, like California, require informed consent from the patient before PGD is performed. Overall, PGD is legal in the US. However, laws may vary from state to state and it is important to be aware of any state-level regulations that may apply to the use of PGD. It is also important to consult with a doctor who is familiar with the laws in the specific state you are in to ensure that you are following all applicable regulations.
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