Study Critiques PMA Process

Last week, the Journal of the American Medical Association published a study examining FDA approvals of PMA cardiology products 2000-2007 PMA.  The study’s authors attempted to draw a parallel between drug and device studies in terms of the extensiveness and rigor of the clinical trials designed to test safety and effectiveness.  However, MDMA President Mark Leahey, commenting in a Los Angeles Times article on the study, stated that it is not appropriate to draw conclusions on device safety by comparing drug and device trials.   MDMA strongly believes that it would be unethical to perform double blinded, randomized trials on patients by implanting them with sham devices in a study.  Moving forward, MDMA will continue to educate lawmakers on the current approval process for medical devices.