Affordable means reasonably priced. In other words, their test can't cost 150 times what other tests cost even if it is slightly more effective. Affordable being relative to what other products are selling for, not who can afford to buy it.
Product has to be "substantially equivalent" to other products marketed for the same use.
You prove that by saying how much your product will cost then, now get this, the FDA will actually check prices of other products (I know, right, crazy)
Turns out affordable doesn't just mean what you can afford. It actually means if a product is competitively priced compared to other related products (I know, wow, groundbreaking)
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