FDA warning letter to Sironis, Inc.

FDA issued a sponsor warning letter to Sironis, Inc. today and cited the following:

  • Failure to submit and obtain FDA approval of an IDE application, and failure to ensure than an Institutional Review Board was promptly informed of significant new information about an investigation.
    • Failure to submit an IDE to the FDA. FDA notes that the results of the trial were published. FDA instructs Sironis not to perform any further investigations of the device until FDA approval is obtained.
    • Failure to notify the IRB of significant new information. Specifically, the inclusion/exclusion criteria on the CRF were changed, but the protocol was not amended and the IRB was not notified.
  • Failure to ensure that information given to subjects as part of the informed consent process complies with the regulations for informed consent.
    • The informed consent failed to include the reasonably foreseeable risks of injury or death from having too much or not enough fluids. 
    • The informed consent did not contain other risks such as delayed surgical wound healing, myocardial ischemia, life-threatening arrhythmias, cerebral ischemia, pulmonary infarction, respiratory failure, and urinary retention.
    • The informed consent did not include a disclosure of appropriate alternative procedures that might be advantageous to the subject.  It stated  that “there are no alternative treatments or procedures available” when standard of care treatment could have been made available as an alternative.
    • FDA notes that an updated informed consent will need to be reviewed as part of the IDE review process prior to any clinical study of the device going forward.

In addition to these findings cited in the warning letter, FDA also notes the following:

  • Sironis failed to clearly document records related to device malfunctions, device software upgrades, and device repairs and why these upgrades and repairs were performed. 
  • Sironis provided a list of software upgrades, case notes, and dates, but the reasons for the upgrades were not explained. This list also only accounted for 47 of the 66 subjects that were enrolled in the study
  • The records of component devices used for each subject were not documented.