'FDA adjusting regulatory structures with evolving science' with US approval of first DTC genetic test
This article was originally published in SRA
Executive Summary
In addition to approving the first ever direct-to-consumer genetic test in the US, the Food and Drug Administration has announced that it intends to ease up its regulatory oversight of such tests that are offered to the public for screening of possible gene disorders by classifying them as Class II (medium-risk) devices and exempting them from for premarket review1.