FDA’s Message to Medical Device Company: Stop


The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious diseases,” including diabetes, coronary heart disease, and breast cancer. This all sounds good. As an FDA Warning Letter issued on November 22, 2013, makes clear, however, 23andMe was marketing its product – a medical “device” under the federal Food, Drug & Cosmetic Act – without benefit of FDA approval. FDA thus ordered the company to immediately discontinue marketing.

The FDA’s Warning Letter to 23andMe is of interest on several levels. First, there is the interest in the cutting-edge technology of the very personalized medical information which the product offers. The promise to “learn more about [one’s] health and ancestry” that the company makes on its website is exciting and enticing.

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Topics:  23andMe, FDA, FDCA, Genetic Testing, Medical Devices

Published In: Communications & Media Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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