FDA To Fast-Track High-Tech Medical Devices

Law360, New York (February 8, 2011, 5:34 PM EST) -- The U.S. Food and Drug Administration announced a program Tuesday to streamline review of breakthrough medical devices such as a brain-powered prosthetic, its latest proposed change to an approval process panned by critics for allowing unsafe items to enter the market.

The FDA's Innovation Pathway initiative would fast-track approval for "truly pioneering" medical devices deemed to hold the potential to revolutionize patient care, the FDA said in a statement. The agency has selected a brain-controlled, upper-extremity prosthetic as a pilot product to kick off the Pathway...
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