Hamlin, Charles M.D. – FDA Warning Letter, Feb 21, 2008

This Warning Letter details objectionable conditions observed during an FDA inspection of Hand Surgery Associates, PC, from January 30 to February 21, 2008. The inspection assessed compliance with federal regulations for Dr. Charles Hamlin's activities as both sponsor and investigator in the [redacted] prosthesis study, a significant risk device.

Serious violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Section 520(g) of the Act were identified. Key violations include:

1. **Failure to obtain IDE approval:** Dr. Hamlin used the [redacted] device in 47 subjects without prior FDA approval, violating 21 CFR 812.20(a), 812.40, 812.42, 812.100, and 812.110(a). 2. **Inadequate informed consent:** No written documentation of informed consent for some subjects, use of unapproved consent forms, and consent obtained after device implantation for others, violating 21 CFR 50.20, 50.27(a), 812.100, and 812.140(a)(3)(i). 3. **Failure to follow investigational plan:** Enrolling 4