FDA WARNING_LETTER - Dennis J. Hurwitz, M.D. - April 02, 2013

This FDA Warning Letter, dated September 30, 2013, addresses objectionable conditions observed during an inspection of the Hurwitz Center for Plastic Surgery from March 13 to April 2, 2013. The inspection assessed compliance with federal regulations for the clinical study of the Invasix Body Tite device, a significant risk device lacking an FDA-approved Investigational Device Exemption (IDE).

Violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects) were identified. Key deficiencies include: 1. **Failure to obtain and document informed consent:** For four subjects, signed consent forms were either missing or obtained after the investigational use of the device. The provided response, attributing this to lost forms, was deemed inadequate as it lacked a preventive action plan. 2. **Inadequate informed consent document:** Consent forms for multiple subjects failed to describe reasonably foreseeable risks, such as those associated with additional procedures (Limited Abdominoplasty) or general anesthesia (e.g., nerve injury, heart attack). The response, citing verbal disclosure and clerical error, was insufficient without a preventive plan. 3. **Failure to conduct the investigation according to the plan and regulations:** * Subjects underwent additional plastic surgery procedures (Limited Abdominoplasty) not described in Protocol RAL 1. * Subjects received general anesthesia, which was not