FDA Issues Safety Communication About Genetic Non-Invasive Prenatal Screening Tests

The Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as “NIPS” or “NIPT”).

FDA’s main concern with NIPS appears to be that FDA has not reviewed the performance of most of these tests because of their regulatory status. Perhaps most tellingly, the safety communication was released just as Congress is considering the Verifying Accurate Leading-Edge IVCT Development (VALID) Act and other legislative initiatives addressing FDA’s regulatory authority over laboratory developed tests (LDTs).

The VALID Act would create a new framework that would authorize FDA to regulate all diagnostic tests (i.e. commercial in vitro diagnostic (IVD) test kits as well as LDTs) as In Vitro Clinical Tests (IVCTs) under a risk-based framework that would be separate and distinct from the medical device framework. NIPS tests would be regulated by FDA under the VALID Act, if it is passed.

 

Source: https://www.jdsupra.com/legalnews/fda-issues-safety-communication-about-6703837/