FDA Alters Medical Device Panel Processes

WASHINGTON, April 26 (UPI) — The U.S. Food and Drug Administration says it is changing the way its expert panels review and discuss data and information during public hearings.

In the past, panel discussions have not always reflected a panel’s final vote on approval, the FDA said. Now, instead of voting to approve a premarket application, the panels will vote on the safety and effectiveness of a device and the device’s 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,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”

In addition, panels will vote by ballot instead of by a show of hands. While the votes will be publicly tallied so that panel members can be identified by their vote, the FDA said the ballot process allows each panel member to cast his or her vote without immediate influence by other votes.

The change is effective Saturday.

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