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FDA Warning Letter

  1. Failure to submit and obtain FDA approval of an IDE application, and failure to ensure that an Institutional Review Board was promptly informed of significant new information about an investigation. A sponsor is responsible for submitting an IDE application for an investigation of a significant risk device to the FDA, and shall not begin an investigation until FDA has approved the application.  You began the investigation prior to FDA approval by enrolling subjects in the study and you made changes to your investigational plan without promptly informing the Institutional Review Board (IRB) of this significant new information.
  2. Failure to require that information given to subjects as part of informed consent is in accordance with regulations.When seeking informed consent, a description of any reasonably foreseeable risks and discomforts to the subject shall be provided to each subject. You did not adequately describe the risks to the subject in your informed consent document (ICD). In your original ICD, you described the risk as merely that the subject “might receive too much or not enough fluids.” Although the revised ICD in your written response contains some additional risks, you did not explain all of the reasonably foreseeable risks of injury or death from having too much or not enough fluids. Other applicable risks that were not identified in your revised ICD include the risks of delayed surgical wound healing, myocardial ischemia, life-threatening arrhythmias, cerebra ischemia, pulmonary infarction, respiratory failure, and urinary retention.

 

 

Link to Full Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm462754.htm