Originally published April 27.
Instead of voting on whether a medical device under premarket review should be approved by the US Food and Drug Administration, the agency's Medical Device Advisory Committee will now vote on the safety and effectiveness of the device, as well as its risk/benefit profile.
Previously, the Medical Device Advisory Committee's discussions about a particular medical device application have not always been reflected in its final vote on whether the FDA should approve the device, the agency noted in announcing the change.
“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,” Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.
The procedural changes will certainly impact any in vitro diagnostic multivariate index assays or predictive pharmacogenetic tests that the FDA is considering through a PMA application and is reviewed by the Medical Device Advisory Committee. The FDA has indicated that if a firm wishes to include information about a companion test on a drug's label, then the test must be reviewed and approved by the agency either through a 510(k) clearance or a PMA.
The FDA is hoping that these modifications will help panelists focus on the scientific aspects of the device that will in turn inform FDA's regulatory decision making. “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," Shuren said. FDA's advisory committees are made up of experts from various scientific and technical fields that offer the agency independent recommendations about aspects of a medical product under review or a medical issue.
The procedural changes, effective May 1, were spurred by the increasing number of meetings the Medical Device Advisory Committee has held in the past two years. In 2008, there were 10 panel meetings covering 14 major topics, and in 2009, there were 17 meetings on 20 topics. "2010 is on track to surpass those numbers," the FDA's CDRH said in a statement.
"The increased activity has created challenges for CDRH and the way it operates panel meetings," the agency said.
Another change is that now panelists will be voting simultaneously via an electronic system, instead of through a show of hands, in an effort to minimize undue influence among committee members.
"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," the agency explained.
Furthermore, the FDA will also change how it presents data on medical devices to the advisory committee — another measure against influencing committee members' votes.
"Before the changes, the agency medical device reviewers presented a unified, consensus analysis of supporting data," the FDA stated. "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."
In addition to these specific changes to the Medical Device Advisory Committee, the FDA also issued a draft guidance for disclosing and minimizing financial conflicts for advisory committee members.