I also have huge issues with an article that uses the phrase "FDA approval" at least 3 times. @matthiasshaphttps://twitter.com/gedankenstuecke/status/762626179107000320 …
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Replying to @EmilyGorcenski
The FDA does not approve Class 2 medical devices, it clears them for marketing. There is a distinction.
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Replying to @EmilyGorcenski
23andme was cleared through the de novo pathway. And the FDA does not need to "check things 10 times", but clinical trials are needed.
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Replying to @EmilyGorcenski
If you want to read the FDA's Decision Summary on 23andme: http://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf … Strangely absent from
@matthiasshap's piece.2 replies 0 retweets 1 like
Unless I'm missing a link. On mobile, so possible.
7:35 AM - 8 Aug 2016
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