FDA to exempt some genetic tests from premarket review

FDA implemented a new regulatory pathway for genetic health risk (GHR) assessments on Monday by classifying all GHR tests as low to moderate risk class II devices with “special controls.” By doing so, the agency said it is reducing regulatory burdens for direct-to-consumer tests that assess genetic predisposition, as long as they meet certain criteria "that provide reasonable assurance of the safety and effectiveness of the device."

In April, FDA approved the Personal Genome Service (PGS) GHR test from 23andMe Inc. (Mountain View, Calif.) through the de novo classification premarket review pathway. At the time, FDA determined that 23andMe's test could be classified as class II with special controls that, in addition to general controls, assured the test's accuracy, reliability and clinical relevance. The test assesses genetic risk for 10 diseases and conditions...