Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent back? I heard this and thought it was a crazy statistic. Is it really that high?

Then I spoke with a couple of other regulatory experts—one who consults with the FDA and another who is a former FDA reviewer—and each confirmed that the statistic sounds about right.

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