The company asked me what I would do now that the FDA is
The company asked me what I would do now that the FDA is shut down and cannot begin review of the company's GenChoice 510K. I told them that in my experience get the "K" number (a lawyer can do this) and then start selling Internationally but not until. I expect the first sales to be in South America and India. That is where I sold my last two new products while awaiting a 510K. Also receipt of a 510K number will allow for expedited review in the EU for a CE mark.
I also expect that the GenChoice product to almost immediately to leak into the U.S. market and that is why I would not recommend selling Internationally just quite yet. Advertising yes, but not yet shipping cases of GenChoice. I would hope that the company has its plan ready to go.
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