FDA approval? We don't need no
stinking FDA approval! Wait, we do? Whoops.
23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without "marketing clearance or approval." "FDA is concerned about the public health consequences of inaccurate results from the PGS device," the agency said today. "The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work."
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