Solta Medical, Inc. – FDA Warning Letter, Aug 17, 2012

The FDA issued a Warning Letter to Solta Medical, Inc. following an inspection from July 12 to August 17, 2012, regarding their clinical studies for the ISIS Laser, Serenity Skin Rejuvenation System, and Janus Resurfacing Laser. The inspection revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects).

Key violations include: 1. **Failure to include all appropriate elements of informed consent (21 CFR 50.25(b)(1))**: The informed consent forms for ISIS and Serenity laser studies did not explicitly state potential unforeseeable risks to the subject, embryo, or fetus, particularly concerning pregnancy. Solta's initial response was deemed inadequate due to insufficient supporting documentation. 2. **Failure to provide investigators with necessary information and ensure proper monitoring (21 CFR 812.40)**: Solta did not perform site initiation visits or adequately train investigators on study protocols and regulatory requirements, increasing risks of medical complications like eye injury, scarring, and infection. Monitoring visits were infrequent or conducted only at study close-out, delaying detection of serious problems. Solta's response was inadequate as it lacked preventive measures. 3. **Failure to obtain signed investigator agreements and sufficient financial disclosure information (21 CFR 812.43(c) and