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It's actually kind of hard to tell -exactly- what the FDA wants without reading the original 510(k) submission. The claims by the FDA directly tie into the orig

It's actually kind of hard to tell -exactly- what the FDA wants without reading the original 510(k) submission. The claims by the FDA directly tie into the original claims by 23andMe as their intended use. In any case, the FDA right now doesn't just want a change of copy. By "cease marketing", I presume they don't mean advertise it differently, they mean stop offering the product to customers - period. While the FDA certainly appears to be taking issue with the specific marketing copy, they seem to be more annoyed that 23andMe has basically failed to complete the regulatory submission process - amongst other things failing to provide evidence to the FDA that their product actually works as intended.

mbreese 13y ago
> 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.
tptacek 13y ago
"[...] we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification [...]". Incidentally, the FDA is lagging a lot of other criticism and restrictions on the 23AM service; for instance, you can't even buy the service in Maryland, which forbids any home lab testing for health conditions not administered by licensed professionals. Similarly, there have been many critiques in the media and elsewhere about the lack of rigor in the 23AM analysis, relative to the importance of some of the conditions the service is implicated in.

mbreese 13y ago

> 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.

tptacek 13y ago

"[...] we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification [...]". Incidentally, the FDA is lagging a lot of other criticism and restrictions on the 23AM service; for instance, you can't even buy the service in Maryland, which forbids any home lab testing for health conditions not administered by licensed professionals. Similarly, there have been many critiques in the media and elsewhere about the lack of rigor in the 23AM analysis, relative to the importance of some of the conditions the service is implicated in.