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.
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.