a device within the meaning of section 201(h) of the [Food, Drug and Cosmetic] Act ["FDCA"], 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.The FDA asserted its authority to regulate approval and sales of this "device."
On January 15, 2014, in the leading international science journal, Nature, Robert C. Green (Associate Professor of Medicine, Division of Genetics, Brigham and Women’s Hospital and Harvard Medical School, and Associate Director for Research, Partners HealthCare Center for Personalized Genetic Medicine) and Nita Farahany (Director, Science & Society, Duke Institute for Genome Sciences & Policy, Professor, Law and Philosophy, and Professor, Genome Sciences and Policy) published an insightful critique of the FDA's decision to regulate consumer genomics. They conclude as follows:
We believe that 23andMe should be more transparent about how accurate its genotyping chips are, and even more forthcoming about the limitations of its computer algorithms used for estimations of risk. But regulatory constraints might stifle consumer genomics and other emerging products that could make society healthier and that do not fit neatly into the model of physician-driven health care. The effects of these products should be monitored but, as long as emerging empirical data show no evidence of harm, we urge the FDA to let consumer genomics testing proceed.The FDA would do well to take notice.