Regulatory Affairs

FDA Issues Labeling Advice for Intravascular Devices

In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and therapeutic vascular procedures. Read More

BD Settles Georgia Lawsuit Over Sterilization Plant

Becton, Dickinson has entered into an agreement with the state of Georgia to settle litigation by the state’s Attorney General aimed at temporarily stopping BD from operating its Covington medical device sterilization facility. Read More