Re:FDA Warning Letter to 23andMe
by mbreese on Monday November 25, 2013 @11:33AM
(#6795038)
> It's actually kind of hard to tell -exactly- what the FDA wants without reading the original 510(k) submission
Well, you don't get this far into trouble with a regulatory agency without having a contact within the agency that you are working with. So, I'm fairly certain that 23andMe probably knows what the FDA wants, but they might disagree. I'll be disappointed in the company if they have ignored the FDA all these years when it was obvious that they'd need to have some sort of approval (even if it was an FDA acknowledgement that they didn't fall under regulation).
What I really want to know is what 23andMe's response to the FDA will be. They must have known this was coming and should have a press release today.
Well, you don't get this far into trouble with a regulatory agency without having a contact within the agency that you are working with. So, I'm fairly certain that 23andMe probably knows what the FDA wants, but they might disagree. I'll be disappointed in the company if they have ignored the FDA all these years when it was obvious that they'd need to have some sort of approval (even if it was an FDA acknowledgement that they didn't fall under regulation).
What I really want to know is what 23andMe's response to the FDA will be. They must have known this was coming and should have a press release today.