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FDA Overhauling Key Medical Device Regs
Podcast: August 16, 2010The Burrill Report (August 16, 2010): FDA Readies Overhaul of Key Medical Device Regulations(.MP3,14.98 Mb)
The U.S. Food and Drug Administration is in the process of overhauling a critical set of regulations relating to the introduction of new medical devices. The agency says the proposed changes have the goals of fostering innovation while better assuring the safety and efficacy of new devices. Medical device makers, though, are concerned about the FDA adding to their regulatory burden without making meaningful improvements in patient safety. We spoke to Carmelina Allis, former assistant chief counsel for enforcement at the FDA and an attorney with Hyman, Phelps & McNamara, about the proposed changes, how far they reach, and why there’s concern that they fall short of balancing the differing goals of encouraging innovation while improving safety.
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