In the industry's words
This article was originally published in SRA
Executive Summary
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the potential changes threaten its position as global leader in the supply of these products. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, warns against any move that might lead to a major weakening of medtech innovation
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