date:May 11, 2012
medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.
In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.
The FDA will continue to monitor