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Regulatory Affairs Medtech
Congress warned against reversing US FDA's pre-emption authority
14 August 2009
Vibha Sharma

A US Senate committee has been warned that there could be “regulatory chaos” if proposed legislation that seeks to overturn the pre-emption authority of the US Food and Drug Administration over medical devices is signed into law 1.

Former FDA chief counsel Peter Barton Hutt said the Medical Devices Safety Act of 2009 (S 540) would allow judges and juries throughout the country not only to impose requirements that are inconsistent with FDA determinations, but which differ from one court to another...

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