FDA commissioner: Ethicon appeal of PMA rejection moves forward

March 21, 2011 by MassDevice staff

FDA commissioner Margaret Hamburg green-lights a new review of a gastro-enterology procedure sedation system made by Johnson & Johnson's Ethicon Endo-Surgery division, which was denied a PMA last year.

Ethicon Endo-Surgery logo

Ethicon Endo-Surgery Inc. has been granted another review of its Sedasys System by the office of the FDA commissioner, a potential victory for the Johnson & Johnson (NYSE:JNJ) subsidiary and its appeal of the agency's PMA denial for its sedation system for gastro-enterology procedures.

The FDA issued a public notice saying that, "after independent study of the data and information furnished by the parties, and other data and information before it, the advisory committee will submit to the commissioner a report and recommendation with respect to the order, together with the underlying data and information and a statement of the reasons or basis for the recommendation."

Ethicon sent a letter of appeal to the Food & Drug Administration in November 2010, after a pre-market approval application for its Sedasys system was denied.

The company first filed a petition for reconsideration in March 2010, after receiving its first non-approval notification from the Center for Devices & Radiological Health, the FDA's medical device arm. The CDRH, however, responded with another denial letter in October.

Appeal is a rarely used part of the PMA application process that device and drug companies can pursue when one of the centers within FDA denies an application, according to the company. Ethicon said if the office of the commissioner grants the appeal, the FDA would appoint a new advisory committee and hold a public hearing on the device. The final decision would then be in the hands of FDA commissioner Dr. Margaret Hamburg.

EES describes the Sedasys System as a "first-of-its-kind computer-assisted personalized [propofol] sedation system for colonoscopy and upper gastrointestinal procedures." The company designed the device to provide integrated patient monitoring with personalized drug delivery. The device "would help reduce sedation-related risks associated with colonoscopies, improve the overall patient experience, and encourage more individuals to be screened for colon cancer, which kills more than 50,000 Americans each year," according to the company. The system has already received CE Mark approval in the European Union and Australian approval.