FDA WARNING_LETTER - Ziran, Bruce H., MD - May 02, 2008

The FDA issued a Warning Letter to Dr. Bruce H. Ziran following an inspection from April 23 to May 2, 2008, at St. Elizabeth Health Center, identifying serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects).

Key violations include: 1. **Conducting an investigation without FDA approval (21 CFR 812.110(a)):** Dr. Ziran allowed subjects to participate in a study investigating an unapproved combination use of a device ([redacted]) with other devices ([redacted] or [redacted]) without an FDA-approved Investigational Device Exemption (IDE). The FDA-approved indication for the [redacted] was for its use alone. The response was incomplete as it lacked documentation of notification to all subjects. 2. **Failure to maintain accurate, complete, and current informed consent records (21 CFR 812.140(a)(3)(i)):** Consent forms for [redacted] subjects were dated after the study procedure. The provided corrective action was inadequate, lacking policies, procedures, and training documentation to ensure informed consent is obtained prior to study procedures and records are properly maintained. 3. **Failure to ensure all required elements of informed consent were documented and provided (21 CFR 50.25(a) and