Combination products was another hot topic that came up during "Regulatory Considerations for Conducting Clinical Trials of Medical Devices," by Elisa Harvey, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA. She said that regulations apply to all clinical studies, and that clinical trials need to be designed differently depending on the objective and regulatory pathway to market. She recommended visiting the FDA's "device Web site" for moreinformation. Perhaps Harvey's most memorable observation was her prediction that "in 10 years, everything will be a combination product."
--By Jim Butschli, Editor