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 field safety notice for Cordis’ S.M.A.R.T. Control Nitinol stent system due to a sterility breach in all pouches of the stent system. The defect was detected during in-house testing on non-production product as part of a development project.