[ExI] FDA Tells Google-Backed 23andMe to Halt DNA Test Service

Brian Manning Delaney listsb at infinitefaculty.org
Tue Nov 26 21:30:09 UTC 2013


El 2013-11-26 21:21, BillK escribió:
> On Tue, Nov 26, 2013 at 6:59 AM, Brian Manning Delaney  wrote:
>> Possible viral -- actually, mainstream media... -- falsehood warning. The
>> FDA letter (http://www.fda.gov/.../WarningLetters/2013/ucm376296.htm) as I
>> read it, only orders 23andMe to stop marketing the saliva collection kit.
>> ("23andMe must immediately discontinue marketing the PGS until such time as
>> it receives FDA marketing authorization for the device.") Is marketing it
>> (for a particular purpose) the same as /selling/ it (without mentioning
>> said, or any, purpose)? Doesn't seem like it, but I'm no expert in
>> regulatory law.
>>
>
> 'Marketing' as the FDA regulations use the term, means 'Offering for sale'.

Makes sense of course, but it would have been clearer if they had just 
written "stop selling".

It is curious, however, that selling is precisely what 23andMe has not 
stopped doing. I know someone who purchased a kit (well, ordered and 
paid for a kit) a few hours ago.

Brian




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