FDAnews
www.fdanews.com/articles/134288-study-calls-for-more-fda-scrutiny-of-medical-devices

Study Calls for More FDA Scrutiny of Medical Devices

February 15, 2011
A new study of medical devices that were recalled by regulators for serious safety issues found many had been approved by regulators through a controversial pathway that usually doesn’t require rigorous studies to prove safety and effectiveness.
Star Tribune