FDA WARNING_LETTER - Pozner, Jason M.D. - March 24, 2010

The FDA issued a Warning Letter to Jason Pozner, M.D., on June 25, 2010, following an inspection from February 12 to March 24, 2010, at his clinical site in Boca Raton, FL. The inspection assessed compliance with federal regulations for the UltraShape® Contour Plus™ System clinical study (IDE # (b)(4)).

Violations of 21 CFR Part 50 (Protection of Human Subjects) and Part 812 (Investigational Device Exemptions) were identified. Key deficiencies included:

1. **Misrepresentation of Investigational Device (21 CFR 812.7(d)):** The clinic's website represented the UltraShape™ device as "safe, effective and uniform treatment," despite its investigational status. The response stated this was an oversight by an outside firm, and a new marketing department would ensure compliance. This response was deemed adequate, pending future verification.

2. **Failure to Conduct Investigation According to Plan/Regulations and Supervision (21 CFR 812.110(b) and (c)):** * Late review of screening lab reports (2-7 weeks post-treatment) for subjects 024 and 003, leading to subject withdrawal due to clinically significant out-of-range values. * Incorrect user manual (Contour 1 System instead