FDA WARNING_LETTER - William C. Domb, DMD - October 16, 2014

The FDA issued a Warning Letter to William C. Domb, DMD, following an inspection from September 18 to October 16, 2014, regarding his role as sponsor-investigator for a significant risk clinical study involving ozone generators. The inspection revealed serious violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects).

Key violations include: 1. **Failure to obtain FDA IDE approval:** Dr. Domb initiated sixteen clinical sites and treated three subjects with ozone generators, classified as significant risk devices, without an approved Investigational Device Exemption (IDE) from the FDA and IRB approval. This exposed subjects to increased harm. 2. **Inadequate investigational plan:** The plan lacked a written protocol with study endpoints, statistical analysis, a risk analysis and minimization plan, a description of the device model and ozone administration parameters, and procedures for monitoring data safety. 3. **Failure to select qualified investigators and obtain agreements:** Dr. Domb permitted an unqualified podiatrist to participate and failed to obtain signed investigator agreements, financial disclosure information, and curricula vitae from all sixteen investigators. 4. **Failure to ensure proper informed consent:** Informed consent documents used for three subjects omitted critical information, including risks, benefits, confidentiality, financial burden, contact information, and voluntary participation statements. 5. **Failure to ensure proper monitoring:** No documentation indicated any monitoring of the investigation since its