The FDA has sent a warning letter to Sironis, a medical devices and software developer, for running an unapproved clinical trial of its LIR closed-loop fluid administration system. The FDA said the Newport Beach, Calif.-based company never sought the proper approvals.
In the warning letter, the agency flagged Sironis for serious violations of clinical trial regulations.
“Your firm began an investigation of a significant risk device on Nov. 15, 2012, and failed to submit an IDE application to FDA,” said the letter.
“We also note that you failed to clearly document records related to device malfunctions, device software upgrades and device repairs, and why these upgrades and repairs were performed. In your written response, you provided a list of software upgrades, case notes and dates, but the reasons for the upgrades were not explained. In this list, you also only accounted for 47 of the 66 subjects that were enrolled in the study.”
The letter gave Sironis 15 days to respond with a plan for corrective actions. Though the letter was dated March 15, the FDA released the letter Sept. 21.