FDA Changes Medical Device Advisory Committee Process

Expert panels reviewing devices for premarket approval will discuss information differently
By Monica Smith
HealthDay Reporter

TUESDAY, April 27 (HealthDay News) -- Because of the increasing number of medical device advisory panel meetings in recent years, the U.S. Food and Drug Administration is changing the way expert panels review and discuss information during public hearings on devices that are being reviewed for premarket approval.

According to the FDA's Center for Devices and Radiological Health (CDRH), the number of panel meetings rose from 10 in 2008, covering 14 major topics, to 17 in 2009, covering 20 topics, and numbers are expected to be even higher in 2010.

The changes to the panel meetings, effective May 1, will address staffing issues, voting procedures and other issues related to information presentation and discussion. The expectation is that the agency will be able to make more effective decisions based on more focused and clear discussions, according to CDRH director, Jeffrey Shuren, M.D. Instead of voting on the approvability of premarket applications, the panel will now vote on the safety and efficacy of a device and its risk versus its benefit.

"By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes," Shuren added. "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."

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