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Comment by gcheong | Hacker News Reader

FDA did not approve it, that is the highest level and requires proof that it is more effective than placebo I believe. The FDA only looked for adverse events in the data and granted authorization to market it as they determined it is very low risk for adverse events. But people will be mislead by the FDA-authorized status as some kind of FDA blessing that it works: https://www.fda.gov/news-events/press-announcements/fda-perm...

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This is false. The FDA does not grant approval to market anything solely on the basis of "low risk for adverse events." The game makers had to run studies demonstrating that it improved ADHD measures. The link you provided says that as well:

"The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools."

Fair enough, I think I came to that conclusion because reading the next statement was just that they determined there were no major adverse events. But I think it still stands that this is only a marketing authorization, the FDA isn't saying it works, so really the company shouldn't be mentioning the FDA at this point unless they go for a stronger classification.

"When the facts change, I don't change my opinion."

Which facts? I was wrong about the evidence needed for marketing authorization but, if I’m not mistaken, they would need that authorization in order to market the product in the first place so mentioning the FDA authorization would, in my opinion, potentially give people the wrong impression that the FDA has endorsed the product at a level (e.g. approval) which I don’t believe the FDA has done at this point.

They have endorsed the product in the only way applicable. There are different processes for drugs and “medical devices” and this one falls under devices. https://www.fda.gov/consumers/consumer-updates/it-really-fda...

They went through "De Novo" premarket review as their medical device was distinct from any previous devices. This is a higher standard than the normal "510(k)" process. Both tracks involve a lot of evidence, a lot of documents, and a lot of scrutiny from the FDA.

They went through the harder track of FDA approval for medical devices.

I have no idea why you seem to think the primary way for the FDA to approve of new treatments is somehow... not them approving of it?

The wording is really poor. "Pre-market authorization" is their approval process. As in, you don't get to tell anybody that your device has any medical benefit unless we've assessed it.

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