FDAnews has teamed Chris Sloan, Quintiles Consulting, and Michael Morton, Medtronic, in a 90-minute presentation on the FDA advisory panel process. You’ll discover tips and guidance that are the fruit of a combined five decades of device regulatory experience.
The Chinese Department of Health has issued a voluntary recall for Biomet Microfixation’s Sternalock Blu Implant Tray. The screw measuring area is inaccurate and could cause the incorrect screw to be chosen by the medical professionals. It is possible that the screw could come into contact with the lung, heart muscle or an artery and result in a pneumothorax or bleeding.