5150sick
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http://www.journalnow.com/business/...cle_53d24090-3c08-5fa8-a67d-30550a862a81.html
"The company is investigating the cause of the incidents with the intent to return to the market after the issue has been resolved. It is offering a refund to consumers."
I'll just copy/paste my comment from the article:
Too bad that under the FDA's draconian "deeming" regulations " intent to return to the market after the issue has been resolved" will cause this to become a "new tobacco product" all over again.
This means that even if the device is Aug 2016 compliant it will not be after they fix the problem.
So by FIXING an issue FDA causes you to fill out another $1,000,000 "new tobacco product" application to which the FDA can just say "sorry, this product isn't substantially equivalent to your older model. You can not sell it in the USA any more"
FDA also gets to keep all that money even if (and when) they deny the application. - 5150
"The company is investigating the cause of the incidents with the intent to return to the market after the issue has been resolved. It is offering a refund to consumers."
I'll just copy/paste my comment from the article:
Too bad that under the FDA's draconian "deeming" regulations " intent to return to the market after the issue has been resolved" will cause this to become a "new tobacco product" all over again.
This means that even if the device is Aug 2016 compliant it will not be after they fix the problem.
So by FIXING an issue FDA causes you to fill out another $1,000,000 "new tobacco product" application to which the FDA can just say "sorry, this product isn't substantially equivalent to your older model. You can not sell it in the USA any more"
FDA also gets to keep all that money even if (and when) they deny the application. - 5150