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And the FDA has been in talks with them since 2009, and with out notice changed its position.
by drakaal 13y ago
And the FDA has been in talks with them since 2009, and with out notice changed its position.
- ska 13y agoThat'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.