FDA and EU Spar on Medical Device Regulation
Sure, the Italians have better food the English richer royal culture and accents and French women don’t get fat but we in America have better medical device regulation, don’t we? Not so fast, says the EU.
They apparently aren’t happy that the FDA is writing internal reports and making public remarks saying medical device regulation, especially high-risk devices, aren’t regulated so well in Europe, according to an internal report quoted in the St. Paul Tribune.
British attorney Paul Ranson told us in that accent that the EU generally thinks it is already doing a nice job regulating medical devices, thank you very much.
“Not in a self-congratulatory way, but I think the sense in the EU is that they are doing it very well,” Ranson told us. And while it’s not the British way to brag, he also allowed that the EU is working on revising its medical device regulations now in an attempt to improve harmonization and centralization, among other issues.
But he called these changes — expected to be unveiled this Summer — to be more like “tweaks and not revolutionary” changes.
“The intention behind the revisions is to improve and strengthen the Directives and to meet growing expectations of European citizens,” Ranson said.
“The current Directives do not offer an uniform level of protection of public health in the European Union and new and emerging technologies have challenged the current Directives,” he added. “In addition, the revisions aim to simplify the Directives delivering a transparent system whereby citizens can be confident in the safety of medical devices.”
As noted in the RAPS piece, EU officials have fired back at FDA personnel who’ve disparaged their regulatory regime.
As we and others have written elsewhere, many in the medical device industry wish the FDA would take some pages from the EU’s regulatory book. Or put another way, the medical device industry wishes the FDA would cut out a lot of the pages in its long regulatory book and adapt more to the relatively streamlined approach in the EU.