News | April 27, 2010

FDA Changes Premarket Approval Process

April 27, 2010 – The U.S. Food and Drug Administration (FDA) today announced it is changing the way it operates its medical device advisory panels, effective May 1.

The changes, which relate to the way the FDA's expert panels review and discuss information during public hearings on medical devices under review for premarket approval, were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices and Radiological Health (CDRH).

The increased activity has created challenges for CDRH and the way it operates panel meetings. The changes will 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 Jeffrey Shuren, M.D., director of CDRH.

In the past, panel discussions have not always reflected a panel’s final vote on approvability. Now, instead of voting on the approvability of premarket approval applications — including conditions of approval — the panel 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,” Shuren said. “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 ballot process allows each panel member to cast his or her vote without immediate influence by other votes.

With the changes, the FDA’s presentations will continue to include reviews of the agency’s data analysis, but will no longer include comments on approvability.

Before the changes, the agency medical device reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion in the group. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration.

The FDA and CDRH will continue to evaluate panel procedures and make changes when necessary.

A detailed description of changes to panel operations can be found at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices....

For more information: www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices...

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