FDA Warning Letter: Entellus Medical

FDA posted a warning letter this week to a device sponsor. 

Entellus Medical was warned for:

  • Failing to secure compliance of noncompliant investigators
    • FDA notes that sponsor employees were present at procedures that did not comply with the approved trial protocol
    • FDA notes that the eighteen pre-planned protocol violations were not reported to FDA
  • Failing to receive FDA and IRB approval prior to implementing a change to the investigational plan
    • FDA states that the pre-planned protocol deviations were encouraged
    • FDA notes that the pre-planned protocol deviations were documented in monitoring visit reports
  • Failing to notify the FDA and IRB of significant new information
    • FDA notes that FDA was notified of the protocol deviation upon submission of the Annual report
    • FDA notes that the IRB was notified after the FDA inspection
  • Failing to submit changes in the investigational plan to the FDA and IRB prior to implementation
    • FDA states that study subjects were placed at an increased risk of harm