FDA Approval Status for Preimplantation Genetic Diagnosis

Preimplantation genetic diagnosis is a procedure whereby the genetic makeup of an embryo is tested for abnormalities or other diseases. If a genetic disorder is found that is known or suspected to lead to an individual having a handicapped, the donors of the egg and sperm of the embryo will be able to determine whether they want that embryo implanted in the woman’s uterus. Typically, this procedure is used in fertility procedures such as in vitro fertilization.

FDA Debate

Because this testing enables individuals to choose which embryo is implanted, it has raised many ethical and legal debates. Alongside these debates is the question of whether such testing has been approved by the government associations that are responsible for regulating medical procedures. The Food and Drug Administration (FDA) is one of these governing bodies.

To date, the FDA has not approved preimplantation genetic diagnosis procedures. This is not because the procedure is unhealthy, but because there is question about whether the FDA has the authority to approve this type of procedure. The FDA approves food, drugs and medical devices. Preimplantation genetic diagnosis is a procedure; because of this, it is debated whether the it falls within the FDA purview.

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