The U.S. Food and Drug Administration (FDA) has reportedly accepted for review 23andMe’s submission for the premarket approval of a new medical device (510(k) application)—here, a health report from its DNA collection kits assessing customer risk for Bloom syndrome, an inherited disorder apparently associated with short stature and various cancers that often result in death by the mid-20s. Details about FDA’s order that the company cease marketing its home saliva test kits as unapproved medical devices because they were “intended for use in the diagnosis of disease or other conditions” appear in Issue 69 of this Bulletin. According to 23andMe Chief Legal and Regulatory Officer Kathy Hibbs, this marks “an important step in our work with the FDA in the coming months. Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions. More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them.” See 23andMe Blog and Forbes, June 20, 2014.