Investigator Conducts Device Study Without an IDE

A researcher conducted a clinical trial of an implanted device without getting FDA approval or informed consent, according to a warning letter. Bruce Ziran, director of orthopedic trauma at St. Elizabeth Health Center served as principal investigator but never applied for an investigational device exemption (IDE), the FDA says. Ziran told the FDA he “believed that since the study was vetted by the sponsor as well as every participating [institutional review board, he] would have been informed of the need for an IDE and there would not be any regulatory concerns.” However, the FDA says, “You are held responsible for knowing and following the regulations pertinent to your activities as a clinical investigator in FDA-regulated studies.”