An ever-increasing number of FDA expert panels has prompted the agency to change the way it conducts premarket medical device reviews. According to the FDA's Center for Devices and Radiological Health, there were 10 panel meetings covering 14 major topics in 2008, and 17 meetings on 20 topics in 2009. And this year is on track to surpass those numbers.
The changes address staffing issues, voting procedures and other items related to how data is presented and discussed. Most notably, panels will now vote on the safety and effectiveness of a device and the device's risk versus its benefit, rather than approvability of premarket approval applications. Additionally, the FDA's presentations to panels on a devices will no longer include comments on approvability.
"By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes," says CDRH Director Jeffrey Shuren in an FDA release. "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."
The FDA has also tweaked other parts of the process. Panels will vote by ballot instead of by a show of hands, which the agency hopes will help panelists cast their votes without being influenced by other votes. Also, agency medical device reviewers will present a range of scientific opinions about a device's data, rather than coming to the panel with a unanimous ruling on the data. The agency says this will promote more in-depth discussion about a device's safety and effectiveness.
- here's the FDA release