Minn. pols defend FDA’s 510(k) process

08.04.11
Publication: DOTmed News By: Brendon Nafziger

Both Minnesota’s senators and one congressman defended the Food and Drug Administration’s 510(k) clearance process from the Institute of Medicine’s calls to scrap it, with one senator slamming the IOM’s recommendations as “very harmful.”

Sens. Amy Klobuchar (D) and Al Franken (D) and Rep. Erik Paulsen (R) issued a joint statement saying they wanted to preserve the so-called fast track clearance process. They also said they supported “targeted reforms” that would cut red tape and speed up getting new devices to market.

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