Jul 12, 2010 - Inside 23andMe

Update on 23andMe and the FDA

On June 10, 2010, 23andMe received a letter from the Food and Drug administration (FDA) expressing the agency’s view that our Personal Genome Serviceâ„¢ may be subject to FDA regulation.   We have responded to this letter and are in the process of scheduling a meeting with the agency for further discussions.   If you would like to read the letter 23andMe received from the FDA, it can be accessed as a PDF through the following link:

The FDA has announced a hearing about laboratory-developed tests to take place in Washington D.C. on July 19-20, 2010. This hearing will cover a variety of topics, including direct-to-consumer genetic testing.   23andMe will be attending this hearing and offering our perspective on how best to reach the goal shared by our company and the federal government– to encourage innovation in personalize medicine while ensuring that consumers receive the best information possible about their personal genetic information.

We encourage everyone to make their opinions on this important topic known to the FDA by submitting comments by the August 15, 2010 deadline.

  • Written comments can be sent to:
    Division of Dockets Management (HFA-305)
    Food and Drug Administration
    5630 Fishers Lane
    Rm. 1061
    Rockville MD 20852

All comments should be identified as being with regard to Docket No. FDA-2010-N-0274.

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