FDA asks for input on IOM proposal to eliminate 510(k) program

08/2/2011 | MassDevice.com (Boston)

The FDA is seeking comments on an Institute of Medicine report that presses for the abolition of the 510(k) process for clearing medical devices. The IOM report has been met with opposition from the device sector, which says the recommendations do not merit consideration. "Any major modifications made to the agency's premarket review programs should be based on sound science and through thoughtful and transparent discussion," said FDA official Dr. Jeffrey Shuren.

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MassDevice.com (Boston)

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