Study Questions Exemption for DBS, FDA Protests

A new study suggests that the FDA’s Humanitarian Device Exemption (HDE) is being incorrectly used to approve an indication for deep brain stimulation (DBS), but the FDA says the study is flawed. The HDE program provides a device pathway similar to the premarket approval (PMA) process, but while sponsors must demonstrate the safety of the device in trials, they don’t have to demonstrate efficacy. The HDE process raises the question of “whether its research or therapy,” Joseph Fins, the study’s lead author and an ethicist at Weill Cornell Medical College, told CTA.
Clinical Trials Advisor