FDA Warning Letter to 23andMe

Re:FDA Warning Letter to 23andMe by drakaal on Monday November 25, 2013 @10:37AM (#6794588)

The back story is 23andMe declined a federal request for a customers DNA. This was the government backlash as a result of protecting user privacy.

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Re:FDA Warning Letter to 23andMe by ska on Monday November 25, 2013 @01:54PM (#6796073)

That is highly improbable.

This action is a core function of what the FDA does.

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Re:FDA Warning Letter to 23andMe by drakaal on Monday November 25, 2013 @04:50PM (#6797317)

And the FDA has been in talks with them since 2009, and with out notice changed its position.

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Re:FDA Warning Letter to 23andMe by ska on Monday November 25, 2013 @05:33PM (#6797574)

That's not true. The FDA position is unchanged.

They have been in talks since 2009 to help 23andme understand what they need to file, and how to do it. 23andme has (repeatedly, it sounds like) failed to do that.

This notice is a standard corrective action taken by the FDA after failure to complete 510(k) submissions.

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Re:FDA Warning Letter to 23andMe by ben1040 on Monday November 25, 2013 @10:58AM (#6794740)

Do you have a source for this?

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Re:FDA Warning Letter to 23andMe by dkordik on Monday November 25, 2013 @10:57AM (#6794736)

Source?

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