FDA WARNING_LETTER - Brava, LLC - March 14, 2014

The FDA issued a Warning Letter to Brava, LLC, following a February-March 2014 inspection of their "Breast Reconstruction and Augmentation with Brava Enhanced Autologous Fat Micro Grafting" clinical studies (Protocols 2004-02 and 2004-03). The inspection revealed serious violations of 21 CFR Part 812, Investigational Device Exemptions, impacting data validity and human subject protection. Primary violations included the firm's failure to ensure proper monitoring and promptly inform the IRB and FDA of significant new information (21 CFR 812.40, 812.46(a)). This resulted in investigators not obtaining or updating informed consent, and the sponsor failing to address an IRB's withdrawal of approval for an investigator or inform the IRB of the FDA's significant risk determination. Brava also failed to prepare and submit complete, accurate, and timely reports regarding IRB approval withdrawal, informed consent issues, and other requested information (21 CFR 812.150(b)(2), 812.150(b)(8), 812.150(b)(10)). Additional concerns included failure to mitigate study bias for investigators with financial interests and inconsistencies between the firm's website and information brochure. Brava's responses were inadequate. The FDA requires evidence of re-consenting, new SOPs with implementation and training details, and a monitoring plan within 15 working days. A teleconference was requested within two weeks to clarify responsibilities. Failure to comply could lead to further regulatory action.