Friday, April 23, 2010

Food and Drug: New FDA Initiative on Infusion Pumps

Today, the Food and Drug Administration announced a new initiative "to address safety problems associated with external infusion pumps, which are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner." The initiative will include (1) "additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers"; (2) a May 2010 public workshop on infusion pump design; and (3) the launch of a new Web page devoted to infusion pump safety. The Wall Street Journal reported that one of the biggest changes affecting infusion-pump manufacturers would be the FDA's conducting of plant inspections before approving new pumps.

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