The IOM report on the 510(k) clearance process in the US: a starting point for debate
This article was originally published in SRA
Meaghan Bailey and Jack Kent argue that it would be short-sighted to forgo a thorough vetting of the strengths and weaknesses of recommendations by the Institute of Medicine simply because the primary conclusion – that the 510(k) clearance process should be scrapped – seems too extreme to be realistically considered.
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