The Food and Drug Administration (FDA) has agreed to review a submission by 23andMe for a health report focused on Bloom syndrome, a rare condition. Google Inc.-backed 23andMe Inc. recently submitted to the FDA a revised 510(k) application for its direct-to-consumer genetic testing service focusing on Bloom syndrome, the Silicon Valley-based company said. In a…
FDA to Review 23andMe 510(k) for Rare Syndrome
by Glenn S. Demby | Feb 25, 2015 | FDA-nir, National Lab Reporter | 0 comments