FDA WARNING_LETTER - Satyaprakash N. Makam, MD - September 22, 2011

This Warning Letter to Satyaprakash N. Makam, MD, details objectionable conditions observed during an FDA inspection from September 7-22, 2011, concerning the "DURABILITY II" clinical study (IDE (b)(4)). The inspection aimed to ensure compliance with federal regulations (21 CFR Part 812, Part 50, and Section 520(g) of the Act) and protect human subjects.

Violations include: 1. **Failure to ensure legally effective informed consent (21 CFR 50.20, 50.27(a), 812.100):** Subjects (b)(6) and (b)(6) only provided initials and printed names, not signatures and dates. There was no attempt to re-consent. Additionally, subjects (b)(6) and (b)(6) underwent study-related testing before obtaining informed consent. The sponsor had previously raised these concerns in May, June, and August 2009, but corrective actions were delayed until September 30, 2009. 2. **Failure to conduct the investigation in accordance with the signed agreement, investigational plan, and regulations (21 CFR 812.100, 812.110(b)):** * The investigator unilaterally modified the IRB-approved ICD for subject (