FDA streamlines medical device voting process

FDA expert panels plan to change the way they review and discuss data during public hearings regarding medical devices being considered for premarket approval.

Effective May 1, 2010, medical device advisory committees will vote on the safety, effectiveness and risks vs. benefits of devices for which premarket approval applications have been submitted. In the past, panel members voted on the approvability and the conditions of approval for a given device — and final votes did not always accurately reflect panel discussions.

“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “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.”

Changes address staffing issues and voting procedures, as well as other areas, according to the press release. A significant change in the way votes are cast will be the use of a ballot system instead of a show of hands. Officials hope that this will help prevent a single vote from immediately influencing other panel members; however, votes will be publicly tallied and panel members will be identified by their vote after all are cast.

The changes come in response to increases in the number of medical device advisory panel meetings. From 2008 to 2009, device panel meetings increased from 10 to 17 and major topics discussed increased from 14 to 20. Officials expect this number to rise in 2010 and beyond.

The FDA hopes that this new voting process will more accurately present the full range of scientific opinion and enable more in-depth discussions about the safety and effectiveness and risks vs. benefits of devices in question.