by
Heather Mayer, DOTmed News Reporter | April 27, 2010
New way of voting
on device approvals
The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) announced Monday that it will change the way its experts review and discuss data and information regarding medical devices under review for premarket approval. The changes are set to go into effect Saturday, according to the FDA.
The decision to make changes comes after a growing number of medical device advisory panel meetings in the past several years.
The FDA wants to "use the [advisory panel] time more effectively," says Dick Thompson, an FDA spokesman.
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Under the new system, the panel will no longer vote on a device's approvability -- conditions of approval -- but instead on the safety and effectiveness of a device and its risk versus its benefit.
"We wanted to allow experts to give the FDA an expert opinion," says Thompson. "Experts in subjects [related to medical devices] are often not experts in regulation," he noted in reference to the old way of doing things.
Also new to the advisory panel will be the method of voting. Experts will now vote using an electronic ballot instead of a simultaneous raising of hands, according to the FDA statement.
"The ballot process allows each panel member to cast their vote without immediate influence by other votes," according to the statement.
Finally, unlike in the past, when CDRH reviewers presented a unified, consensus analysis of supporting data, they will now present that data and analysis in addition to the range of scientific opinion of group members.
"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," CDRH Director Jeffrey Shuren said in a statement.
As the agency tightens enforcement under the current administration, this move won't loosen approvability, says Thompson.
"What they're after is to allow experts to do what they're best at doing," he says. "Based on that opinion, the FDA will decide clearance and approval."
