FDA Seeks Answers on Trial Design for Devices to Treat Depression

In its quest to create consistency and transparency in designing clinical trials for devices intended to treat depression, the FDA received little help from a recently convened advisory panel. The Neurological Devices Panel struggled in a recent meeting to develop a list of consistent suggestions for devices now in the product development pipeline. Major stumbling blocks included distinct differences among the four types of devices approved to treat depression and a lack of data about those devices to help form any sort of centralized standards.
Clinical Trials Advisor