FDA 483 - Brava, LLC - March 14, 2014

Brava, LLC, a medical device sponsor/monitor in Miami, FL, was cited for significant deficiencies in its conduct of a clinical investigation for the Brava AFT System. The inspection revealed failures in meeting investigational device exemption (IDE) requirements, including issues with informed consent, IRB communication, investigator monitoring, financial disclosures, and adherence to cGMPs and QSR. These observations indicate a serious lack of oversight and compliance in clinical study management.