UPDATE: CDRH chief Shuren blasts Stanford study on medical device regulations (MassDevice)
Center for Devices and Radiological Health director Dr. Jeffrey Shuren fires back at recent study from Stanford University on the costs associated with satisfying Food & Drug Administration rules during the 510(k) process.
: FDA Process “Unpredictable,” “Characterized by Disruptions and Delays” (HealthPointCapital)
Read the full Stanford University report on FDA 510(k) clearance costs (pdf)