Device Trial Sponsor Cited for Late UADE Reports

The director of the Johns Hopkins Comprehensive Diabetes Center failed to report unanticipated adverse device effects (UADEs) in a timely manner and used inadequate or outdated informed consent forms in a device study for which he served as both sponsor and investigator, according to an FDA warning letter. While Christopher Saudek reported UADEs to the FDA via MedWatch reports and the institutional review board, he did not always do so within the required 10 working days, according to the letter.
Devices & Diagnostics Letter