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will include (1) “additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers”; (2) a May 2010 public workshop on infusion pump design; and (3) the launch of a new Web page devoted to infusion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.
This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.
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will include (1) “additional premarket requirements for infusion pumps, in part through issuance today of a new draft guidance and letter to infusion pump manufacturers”; (2) a May 2010 public workshop on infusion pump design; and (3) the launch of a new Web page devoted to infusion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.
This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.