US FDA said Nov. 6 it is implementing a novel "firm-based regulatory approach" to overseeing consumer genetic health risk (GHR) tests that it initiated in April when it allowed 23andMe Inc., to launch the first FDA-validated direct-to-consumer tests predicting individuals' predisposition to genetic diseases and conditions.
The April 6 determination paved the way for FDA's formalization this week of its de novo classification of GHRs as class II devices. In parallel, the agency proposed...