If you look at the FDA's website, it's littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA c

If you look at the FDA's website, it's littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA can evaluate the medical claims they're making. See, e.g., this one from June 10, 2010: [0] http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/... All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy: > 23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™ is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information. The FDA then establishes its ability to regulate this (remember, it's legally required to do this): > During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Service™ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Service™ is a diagnostic device and subject to all applicable requirements of the Act. They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements: > For a device requiring premarket approval, the notification required by section 510(k)of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). There's even a helpful mailing address and fax number: > Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993 Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway.