FDA: Kerry asks Hamburg for more transparency on IOM's 510(k) recommendations

April 13, 2011 by MassDevice staff

Sen. John Kerry (D-Mass.) is throwing his two cents into the debate over the way medical devices are cleared for the U.S. market.

The senior senator from Massachusetts wrote an open letter to FDA chief Dr. Margaret Hamburg, relaying concerns he's heard from constituents in the Bay State's medical device industry that changes to the 510(k) pre-market notification process could be "unnecessarily burdensome and delay life-saving technology from coming to market."

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