FDA WARNING_LETTER - Pattanam D. Srinivasan, MD - September 27, 2013

The FDA issued a Warning Letter to Dr. Pattanam D. Srinivasan, Clinical Director of Advanced Interventional Pain Center, following a September 16-27, 2013 inspection. The letter addresses his roles as sponsor and Clinical Investigator (CI) for the clinical study "(b)(4)" involving a significant risk device. Concerns were also raised about his simultaneous role as head of the Advanced Interventional Pain Center IRB.

The inspection revealed multiple violations of 21 CFR Part 812 (Investigational Device Exemptions) and Part 50 (Protection of Human Subjects). Key violations include: 1. **Failure to obtain IDE approval:** Nine subjects were treated with the (b)(4) device, classified as a significant risk device, without an FDA-approved Investigational Device Exemption (IDE) application, despite prior FDA notification. 2. **Inadequate informed consent:** Informed consent forms (ICFs) were not IRB-approved, contained exculpatory language, and lacked essential elements such as statements about the research nature, voluntary participation, and foreseeable risks. 3. **Failure to maintain accurate records:** Original ICFs and source documents were not maintained for the required two years. Device use and disposition records, including lot codes, were incomplete. Financial disclosure forms for sub-investigators were missing. 4. **Failure to follow investigational plan:** Required follow-up visits at (b)(4