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Re: The Rainmaker post# 82084

Saturday, 08/20/2016 11:25:08 PM

Saturday, August 20, 2016 11:25:08 PM

Post# of 335415
Please note that if Biel gets FDA OTC clearance, it would have taken them over 14 years. This is not a trivial matter.

Also, as the previous poster indicated, when a device is OTC cleared, it is cleared for mechanical safety, but that is the easy part. The FDA also requires clinical trials and efficacy data. It is the latter that makes the most difficult and most stringent worldwide.

When a product is cleared for over the counter, it does not require prescription. One should be able to go to Walgreens, CVS, and Walmart to grab one, besides the online stores such as Amazon, Ebay, etc...

That is why product awareness through marketing and advertising will be an important next step to boost US sale from the current Zero sale to infinity!