3 ms·

I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's op

I'm most curious to see how 23andMe is going to respond to this, because the more technical-regulatory language in this letter says essentially that in FDA's opinion the device is Class III (the highest risk of all medical device/diagnostics) and would require a PMA, unless 23andMe provides the evidence that allow FDA to de novo classify the device as Class II. A Class III ruling would destroy the personal genomics market, because it would mean extensive clincial testing and documentation about the development of the device. I hope it doesn't stand.

esMazer 13y ago
Thank you, and this is the heart of the argument. I also wonder who's behind this push from the agency. It took them 40 years to get the labeling for tylenol right.. http://www.thisamericanlife.org/radio-archives/episode/505/use-only-as-directed http://www.thisamericanlife.org/radio-archives/episode/505/u... They are moving rather quickly on this one... my only question is, why/how??
- dragonwriter 13y ago
  > It took them 40 years to get the labeling for tylenol right.. [...] > They are moving rather quickly on this one... my only question is, why/how?? You are comparing apples and oranges. It didn't take them 40 years to get to the point where Tylenol had to go through the procedure requiring FDA approval for marketing a drug (which is generally similar in origin to the parallel requirement for medical devices.) Likewise, its quite possible that 40 years from now, there'll have been several rounds of changes to how an equivalent personal genomics kit will be marketed based on changes to what we know between now and then.