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Two Paths: Device Reforms In Senate, House Bills Differ Dramatically

Companies should expect much more in the way of FDA reforms than what is contained in the core user fee agreements. The chart compares provisions in the latest available versions of House and Senate bills.

It has become abundantly clear that congressional lawmakers will not be satisfied with passing a simple FDA user fee reauthorization bill this year. Legislation progressing in both chambers of Congress indicates that much more significant regulatory reforms are on the table. (See in this issue, Also see "Senate Committee Moves Bipartisan FDA Reform Bill Toward Floor" - Medtech Insight, 30 April, 2012..)

Exactly what the ultimate reforms will look like remains highly uncertain, however. The Senate plan, approved last week by the Health, Education, Labor and Pensions Committee, is the more bipartisan...

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