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.

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