House Reps Call For Balance In 510(k) Overhaul

Law360, New York (October 13, 2010, 3:35 PM EDT) -- As the U.S. Food and Drug Administration contemplates changes to the 510(k) approval pathway for medical devices, members of the U.S. House of Representatives are asking federal regulators to work closely with industry stakeholders to develop a consensus approach on its most controversial proposals.

The 12 members of the House Energy and Commerce Committee sent a letter Tuesday to FDA Commissioner Margaret A. Hamburg urging the agency to prioritize its rulemaking to focus first on recommendations that have the support of interested parties, and then tackle...
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