21 CFR Part 803
Immune Bioscience will track adverse events and report to FDA under 21 CFR Part 803. A website is available to report on adverse events, and this website is referenced in the Fact Sheet for Health Care providers as well as through the Immune Bioscience Support.
Each report of an adverse event will be processed according to Immune Bioscience’s Non-Conformance Reporting Requirements, and Medical Device Reports will be filed with the FDA as required.
Through a process of inventory control, Immune Bioscience will also maintain records of device usage/purchase.
Immune Bioscience will collect information on the performance of the test, and report to FDA any suspected occurrence of false positive or false negative results of which Immune Bioscience becomes aware.