Tag Archives: CE

The future of device regulations: the EU model or the FDA approach?

The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be…


A really bad idea: FDA conducting CE research

The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up…