Dealmaking in 2009: A Look Back and A Glance Ahead
This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010.
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As the House and Senate work to meld their respective 2,000-page health care reform bills into a single politically viable plan, the device industry remains most intently focused on a mere seven pages of each: the device tax provisions
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FDA's device center wants to make the 510(k) process more predictable, but one of the first steps to accomplishing this is to break from what CDRH acknowledges are some questionable past decisions, according to a top Office of Device Evaluation official