The FDA’s Center for Devices and Radiological Health (CDRH) is making several changes to the way its expert panels review and discuss information at panel meetings on devices under premarket review during public hearings.
According to a news release from the agency, the changes are a result of an increasing number of medical device advisory panel meetings in recent years. Among the noted changes will be in regard to staffing issues, voting procedure and panel deliberations, as well as other issues related to information presentation and flow of discussion. This year, the FDA believes it will surpass the 17 meetings held in regard to 20 topics in 2009, prompting the need for change, said the agency, as increased activity has created challenges for the operation of panel meetings.
In terms of voting and panel discussions, the panels will now vote by ballot instead of by a show of hands and the reviewers will be able to provide their scientific opinions and recommendations to the questions posed by the FDA without interruption.
Prior to the changes, reviewers of the medical devices presented a consensus analysis of supporting data. The agency said that reviewers will now present together with data and analysis, the range of scientific opinion across the group.
“By taking a broader view of the data that are 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,” said the FDA.
“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 CDRH Director Jeffrey Shuren, MD.
The changes will go into effect on May 1, 2010.