Rodo Medical Inc – FDA 483, Aug 1, 2014

Rodo Medical, Inc. in Sunnyvale, CA, was inspected regarding its role as a sponsor of an investigational device study. The inspection revealed significant deficiencies in the conduct and documentation of a clinical study for the RODO Attachment Device, including initiating the study without FDA approval and lacking proper investigator qualifications and oversight. These issues indicate a severe lack of adherence to regulatory requirements for investigational device studies and human subject protection.