SEDASYS Update

December 7, 2011
 
 

SEDASYS Update

 
On November 28, 2011, Ethicon Endo-Surgery (EES) withdrew its appeal challenging the FDA’s denial of EES’s premarket approval application (PMA) for the SEDASYS Computer-Assisted Personalized Sedation System.   The appeal withdrawal letter is posted at http://www.regulations.gov/#!documentDetail;D=FDA-2010-P-0176-0085. According to the letter, EES and the FDA’s Center for Devices and Radiological Health have settled the appeal.  The FDA has cancelled an advisory committee hearing that was scheduled to review the appeal on December 14. News reports indicate that the FDA and EES have cooperated to address the FDA’s safety concerns and the FDA has agreed to reopen the PMA and review it expeditiously. For additional background, all documents submitted in connection with the appeal may be found here.  A summary of the issues that were subject to review on appeal can be found under “FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney Letter with Attached Summary of Scientific Issues – Summary” with ID # FDA-2010-P-0176-0075 posted on 09/14/11.