FDA aims to require infusion-pump makers to present more data

04/25/2010 | New York Times (tiered subscription model), The

The FDA released draft guidelines that would require additional clinical data from manufacturers of infusion pumps, which can intravenously administer solutions such as drugs and food, before the agency grants marketing clearance. The move comes after the FDA received reports of 710 deaths related to device problems in the past five years. Representatives from infusion-pump makers said they think their products are safe, and they plan to work with the FDA regarding the proposed guidelines.

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New York Times (tiered subscription model), The

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