The FDA slammed Sironis for running an unapproved clinical trial of its LIR closed-loop fluid administration system, saying the Newport Beach, Calif.-based company never sought the proper approvals from the federal safety bureau.
In a warning letter dated March 15 and released by the FDA this week, the agency flagged Sironis for serious violations of clinical trial regulations, saying the company failed to ask for or won an investigational device exemption for the trial.
“Your firm began an investigation of a significant risk device on November 15, 2012, and failed to submit an IDE application to FDA. On December 27, 2013, your firm published findings in a medical journal from a study in which your unapproved device was used. According to your records and the letter to FDA from the University of California, Irvine Office of the Vice Chancellor for Research, dated August 27, 2014, the clinical sites had enrolled 66 subjects,” the FDA said in the warning letter. “Your failure to obtain FDA approval of an IDE prior to subject enrollment may have placed study subjects at increased risk of harm. Without FDA approval, the study lacked the regulatory oversight necessary for the protection of the public health and safety.
“Please do not conduct any further investigations of your device until you have obtained the appropriate FDA approval,” the FDA wrote.
The agency also said Sironis failed to inform an institutional review board about changes to the trial, failed to adequately describe the risks of the trial, and didn’t reveal the existence of alternative treatments as required.
“If you plan to continue clinical research with your device, an approved IDE is needed. No further clinical research may take place with this device until FDA approval of an IDE takes place,” the FDA said.