In hopes of improving discussion and information flow, the U.S. Food and Drug Administration (FDA) is changing the way its medical device advisory committees review and discuss data and information during public hearings on medical devices under review for premarket approval (PMA).
Instead of voting on the approvability of PMA applications (including conditions of approval), the panel will now vote on the safety and effectiveness of a device and its risk versus benefit, according to the FDA.
Panels will also vote by ballot, instead of by a show of hands, the FDA said. Although votes will be publicly tallied so that panel members can be identified by their vote, the ballot process will allow each panel member to cast his or her vote without immediate influence by other votes, according to the agency.
In other changes, the FDA's presentations will continue to include reviews of the agency's data analysis but will no longer include comments on approvability. Also, agency medical device reviewers will present together the range of scientific opinion in the group, rather than presenting a unified, consensus analysis of supporting data. The FDA hopes this change will facilitate more in-depth discussion on safety and effectiveness and risk versus benefit of the device.
For further details on the panel changes, click here.
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