Hamburg Agrees to Hear Appeal of Rejection of Ethicon Device

FDA Commissioner Margaret Hamburg has agreed to hear an appeal by Johnson & Johnson subsidiary Ethicon Endo-Surgery over a nonapprovable letter for Sedasys, a computer-assisted personalized sedation system. As a result, a new independent advisory panel will likely be appointed to reconsider the clinical trial data and PMA for the device. Last year, the Anesthesiology and Respiratory Therapy Devices Panel voted 8–2 in favor of approving the device with certain conditions. This is the second time in 20 years that a company has appealed directly to the commissioner. The last company who used this route failed.
Devices & Diagnostics Letter