AAOS Now

Published 6/1/2010

FDA changes Advisory Committee process

On May 1, 2010, the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) implemented changes to their advisory committee process. According to the agency, the changes were prompted by the increasing number of medical device advisory panel meetings in recent years. In 2008, 10 panel meetings were held, covering 14 major topics. In 2009, 17 meetings were held on 20 topics, and 2010 is on track to surpass those numbers.

The increased activity created challenges for CDRH and the way it operates panel meetings. In accord with current agency policy and guidance for advisory committees, the changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion.

“These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts,” said CDRH Director Jeffrey Shuren, MD.

The CDRH advisory committees will now vote only on the safety and effectiveness of a device and its risks versus benefits. Previously, the committees voted on the approvability of premarket applications, including the conditions of approval.

“This change in voting procedure will enable panel members to address key scientific issues during their discussions, which will be reflected in their votes,” said Dr. Shuren. “The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.”

The panel will allot more time for discussion without interruption and may engage with both the sponsor and the FDA, if requested. This discussion is intended to provide the CDRH with information to reach a decision on the approvability of the device. Members of the panel will vote simultaneously via an electronic method to ensure that they are not immediately influenced by each other’s vote. The votes will be publicly tallied so that panel members can be identified by their vote. The CDRH’s Orthopaedic and Rehabilitation Devices panel is currently chaired by John D. Kelly IV, MD.