FDA give 23andme 15 days to get into compliance or present a plan to do s

Today's big news is the FDA warning letter to 23andme giving them 15 days to either get into compliance or present a plan for compliance or cease selling the 23andme test as a "medical device" under (b)(4) of the regulations. See this link for the letter:
Warning Letter.

Earlier letters can be found by searching the site at this link: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.