Social Considerations:

Many people are surprised to learn that in the United States, diagnostic genetic tests are not approved by the FDA. However, because many genetic diagnostic tests are patented, industry voluntarily self-regulates by assuring that tests meet good manufacturing practices (GMP) and the standards of CLIA (Clinical Laboratory Improvement Amendments). Thus, in the United States, genetic tests are not approved by the FDA, but may meet CLIA and GMP criteria.

PGD is a medical procedure that involves a genetic test, but like other medical procedures such as surgery does not fall under FDA regulation and oversight. Thus, PGD undergoes "professional self-regulation," which means that professional societies, composed of genetic counselors (National Society of Genetic Counselors--NSGC) and fertility clinicians (American Society for Reproductive Medicine--ASRM) reach an agreement on which procedures are appropriate and issue guidelines for practice.

Because health insurance companies in the United States usually approve procedures, medications, and tests that are covered by state-funded health programs such as Medicaid, and because most of those are FDA approved, PGD is not presently covered by Medicaid. Thus, PGD is usually not covered by health insurance, but IVF may be.