Medical technology company Sironis was cited for clinical trial violations by the U.S. Food and Drug Administration (FDA).
FDA Issues Several Citations to Sironis
Sironis never requested or received an “investigational device exemption” for the trials involving the product in question, a LIR closed-loop fluid administration system.
Details of the Clinical Trials
66 subjects were enrolled at clinical sites, according to the letter to the FDA from August 27, 2014. These subjects were at an increased risk of harm due to improper trial procedures.
The FDA wrote, “Please do not conduct any further investigations of your device until you have obtained the appropriate FDA approval” in a letter dated March 15 that was just released.