The FDA’s Center for Devices and Radiological Health (CDRH) is making several changes to the way it operates expert panels that review and discuss data and information at panel meetings on devices under premarket review.
The number of device panel meetings has risen over the past couple of 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.
This increase in activity brings along challenges the agency is addressing through changes to how it operates panel meetings. In addition to staffing issues, the changes, which are effective as of May 1, 2010, will address voting procedures and other issues related to information presentation and flow of discussion.
- ADVISORY COMMITTEE STAFF
CDRH recently centralized the Designated Federal Officers and hired a staff of six, full-time employees. Centralizing the panel staff will provide improved continuity across CDRH.
- ADVISORY COMMITTEE VOTING PROCEDURE
For meetings focusing on a particular device that is under review in the agency to determine its approvability, panel discussion has not always reflected a panel’s final vote on approvability. Under the new approach, 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 changing the voting procedure in this way, panel members will address key scientific issues during their discussions, which will be reflected in their votes. This change will also allow panel members to address issues related to their scientific area of expertise instead of regulatory issues, with which they may not be so familiar.
To further simplify the voting process, CDRH will move from a simultaneous show of hands to a ballot vote, implementing an electronic voting procedure. 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 their vote without immediate influence by other votes.
- PANEL DELIBERATIONS
In order to provide useful information to both the agency and the sponsors and to allow the panel more time to discuss the issues without interruption, CDRH will instruct the panel to provide their scientific opinions and recommendations to the questions posed by the FDA without interruption. There will be an hour for panel deliberations, during which the panel may ask questions of both the sponsor and the FDA. We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel.
- CDRH PRESENTATIONS
In the past, CDRH reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion amongst the group. By taking a broader view of the data that is supplied and the opinions of different reviewers and offices within CDRH we will provide the panel the ability to have a more in-depth discussion on safety and effectiveness and risk versus benefit of the device at issue.