FDA EIR - Brava, LLC - March 14, 2014

An FDA inspection of Brava, LLC, conducted from February 4 to March 14, 2014, identified significant deficiencies related to the company's investigational device study for the Brava AFT System (Protocol No: 2004-03). The regulatory framework for these findings primarily concerns Investigational Device Exemptions (IDEs), informed consent, and clinical study oversight, as outlined in 21 CFR Part 812 and Part 50. Key violations included a failure to adequately monitor the investigational study, leading to instances where subjects were not properly consented, and investigational devices were distributed to unapproved sites. The company also failed to ensure the study adhered to the approved investigational plan and did not take appropriate action when noncompliance was identified. Furthermore, Brava, LLC neglected to promptly inform Institutional Review Boards (IRBs) of crucial new information regarding changes in the device's risk classification. Additional issues involved the company's failure to ensure subjects were re-consented with updated informed consent forms following study changes and a lack of proper financial disclosure agreements from clinical investigators, specifically concerning a principal investigator's substantial financial ties to Brava, LLC, without detailing steps to mitigate potential bias. Records also lacked statements on compliance with good manufacturing practices for the investigational device. Required actions would involve implementing robust systems for study monitoring, informed consent, IRB communication, financial transparency, and record-keeping to comply with federal regulations governing clinical investigations of medical devices.