The FDA cannot force anyone to buy a device so they can only clear a company to market them (with relevant controls/disclaimers etc). Selling involves finding some one to pay cash for your device - something MFST has failed to do so far and has nothing to do with the FDA.,
Without permission to market you cannot sell. (you get a very stern cease and desist order if you try to sell a device with any medical benefits that are not cleared by the fDA)
Why MFST didnt try to sell overseas in the first place shows how little they really understand the device market and how to sell.
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