Institute Of Medicine Clarifies It Is Not Seeking Tougher Bar For Class II Devices

Article preview from "The Gray Sheet"- August 8, 2011

A week after issuing a scathing assessment of FDA's 510(k) pre-market clearance program, the Institute of Medicine clarified that it is not recommending a tougher pre-market bar for all class II devices.

Institute Of Medicine Clarifies It Is Not Seeking Tougher Bar For Class II Devices

Article preview from "The Gray Sheet"- August 8, 2011

Cognizant of the uproar caused by the July 29 report, which urged FDA to replace the 510(k) program with a new process that better ensures the safety and effectiveness of devices, the IOM committee appears to be downplaying some of its major concerns about the program.

"There was nothing in here that said that we were recommending a tougher, more rigorous, more demanding pre-clearance gateway," IOM committee member William Vodra, retired senior counsel of the law firm Arnold & Porter, said at an Aug. 4 Food & Drug Law Institute event in Washington, D.C. "We're not recommending that we just convert these to PMAs."

Committee member Brian Wolfman, visiting law professor at Georgetown University, formerly of the consumer advocacy group Public Citizen, echoed the sentiment.

"It doesn’t necessarily mean there's going to be more intense pre-market scrutiny for all the devices going through 510(k) now," he said. But he added that "it may mean there is more intense scrutiny for some devices."

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