FDA WARNING_LETTER - South Texas Innovative Medicine - April 08, 2011

The FDA issued a Warning Letter to Donald A. Rhodes, D.P.M. dba South Texas Innovative Medicine, following an inspection from April 5-8, 2011, concerning the (b)(4) device clinical study. The inspection aimed to ensure compliance with federal regulations for investigational device exemptions and human subject protection.

The FDA identified serious violations of 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Section 520(g) of the Federal Food, Drug, and Cosmetic Act. Key violations include: 1. **Failure to obtain Institutional Review Board (IRB) approval:** The sponsor/investigator failed to obtain IRB approval for the (b)(4) device investigation, violating 21 CFR 812.2(b)(1)(ii). This compromises assurance of minimized subject risks, data monitoring, and safeguards. 2. **Failure to obtain informed consent:** The sponsor/investigator failed to ensure proper informed consent from subjects, as required by 21 CFR 812.2(b)(1)(iii) and Part 50. Prototype Treatment Release forms were not IRB-approved and lacked basic elements required by 21 CFR 50.25, thus not documenting consent per 21 CFR 50.27.

The FDA rejected the claim that the (