FDA TO USE OUTSIDE EXPERTS TO EVALUATE ICDS
The FDA will rely on a panel of outside medical experts in cardiac electrophysiology to help determine the safety and effectiveness of defibrillators already on the market, particularly in cases when a device is recalled.
This move marks the first time the agency will look outside the agency for help monitoring devices in the postmarket stage, it said.
But the agency will not be creating a new panel from scratch. Traditionally, the FDA uses outside advisory panels to help decide whether a new device should be approved and it said it will draws from the pool of consultants used by the agency's Center for Circulatory Devices.
"Some of them have just taken on new duties," said Megan Moynahan, chief of the pacing, defibrillation and leads branch in the Center for Devices and Radiological Health's (CDRH) Office of Device Evaluation.
Specifically, the chosen panel will have minimal conflict of interest with heart device companies and will assist members of the FDA via telephone in "time critical" situations, Moynahan told FDAnews. They also will be available "to help interpret data" in postmarket situations where there are recalls or new safety information.
The FDA will be able "to tap into the expert panel of four to five people under rolling conflict of interest," Moynahan said, which means that that experts would be prescreened for minimum conflicts and, if approved, could be called when needed without having to go through normal channels. This is unlike premarket approval situations that take months to facilitate, she said.
While published reports link the FDA's outside panel to a recent report released by devicemaker Guidant, which also recommended an outside advisory board, Moynahan said the two reports are not related.
"This is something that has been brewing at the FDA since last year. There has been a lot of interest and new focus on postmarket issues" but it is no coincidence the panel is being formed on the heels of many ICD recalls, said Moynahan. ()a href="http://www.fdanews.com/ddl/33_16/" target=_blank>