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FDA and EU Spar on Medical Device Regulation

Just paying attention, says FDA; that’s hypervigilence, counters EU

Michael Causey
Tue, 05/01/2012 - 11:43
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Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

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They apparently aren’t happy that the Food and Drug Administration (FDA) is writing internal reports and making public remarks saying medical devices, especially high-risk ones, aren’t regulated so well in Europe, according to an internal report quoted in the Star Tribune and also reported over at the Regulatory Affairs Professional Society (RAPS).

British attorney Paul Ranson told me (with that accent) that the European Union generally thinks it is already doing a nice job regulating medical devices, thank you very much.

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