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Scrip Regulatory Affairs
In the industry's words
02 July 2010

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

What are the most important issues for the US domestic medtech market?

Currently, the most important issues the medical device industry is facing are potential changes to the FDA’s 510(k) review process...

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