[iancmceachern]

I've been part of bringing many medical devices to market and this isn't true.

Sometimes they do publish the validation data, especially in pharma etc. Most times they don't, why would you? It would only help your competitors.

[seehafer]

510(k) summaries are always a negotiation between FDA (which wants as much data as possible in them) and manufacturers (which want as little data as possible, as it is priceless competitive intelligence)