FDA WARNING_LETTER - Michael Ring, MD - August 23, 2012

This FDA Warning Letter, dated January 6, 2015, addresses Dr. Michael E. Ring of Providence Spokane Heart Institute following an inspection from July 24 to August 23, 2012. The inspection assessed compliance with federal regulations for the "Medtronic CoreValve U.S. Pivotal Trial" (IDE G100012).

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include:

1. **Failure to ensure informed consent (21 CFR 50.25(a)(1)-(2), 50.20, 50.27(a), 812.100):** Subjects underwent invasive, research-specific screening tests (e.g., CT angiogram) before signing screening informed consent documents (ICDs). Some subjects were randomized before signing the procedure ICD. While a revised SOP for pre-procedure consent was deemed adequate, the plan for pre-randomization consent was inadequate.

2. **Failure to conduct investigation in accordance with plan and report deviations (21 CFR 812.100, 812.110(b), 812.150(a)(4)):** Emergency deviations from the investigational plan (e.g.,