Rodo Medical, Inc. – FDA Warning Letter, Aug 1, 2014

On February 20, 2015, the FDA issued a Warning Letter to Rodo Medical, Inc. following an inspection from July 29 to August 1, 2014. The inspection assessed compliance with federal regulations for a clinical feasibility study of the Rodo Dental Abutment System, titled "(b)(4)," conducted prior to an Investigational Device Exemption (IDE) submission.

The FDA identified several violations of 21 CFR Part 812 - Investigational Device Exemptions:

1. **Failure to obtain FDA approval for a significant risk device study (21 CFR 812.40, 812.42, 812.20(a)(1)):** Rodo Medical treated nine subjects with the investigational device between August 21, 2011, and March 1, 2013, without an approved IDE. The FDA had previously informed Rodo Medical in August 2011 that the device was considered significant risk due to potential bacterial ingress and required an IDE. Rodo Medical's response was deemed inadequate for not demonstrating understanding of device risk determination and proper disclosure to the IRB.

2. **Failure to properly monitor an investigation (21 CFR 812.2(b)(1)(iv)):** Rodo Medical did not ensure the clinical investigator complied with the signed agreement regarding UCLA Medical IRB