FDA WARNING_LETTER - Saudek, Christopher D. MD - July 28, 2008

The FDA issued a Warning Letter to Christopher D. Saudek, MD, following a July 10-28, 2008 inspection of his clinical site. The inspection assessed compliance with federal regulations for his role as sponsor and clinical investigator in the study "(b)(4)" involving a device.

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

Key violations include: 1. **Failure to obtain adequate informed consent (21 CFR Part 50):** Subjects signed consent forms that did not include new procedures (e.g., (b)(4), (b)(4)) and their associated risks, or the risk of (b)(4). Consent forms also failed to state the (b)(4) used in the (b)(4) was investigational. 2. **Failure to submit timely and complete Unanticipated Adverse Device Effect (UADE) reports (21 CFR 812.150(b)(1), (b)(10)):** At least ten UADEs were not reported to FDA or the IRB within the required 10 working days. MedWatch reports were incomplete, lacking device name or IDE number. 3. **Failure to conduct investigation according to plan (21 CFR 812