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MDMA Statement on FDA's 510(k) Device Modifications Meeting

Thursday, June 13, 2013  
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Washington DC - Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), issued the following statement regarding the FDA public meeting entitled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device:"

"The 510(k) regulatory pathway continues to have a stellar safety record and is one of the reasons the United States leads the world in medical technology innovation.

"It is critical that before any revisions to current statutory and regulatory requirements are made, we identify what the concerns are, and that any possible solutions are targeted.

"MDMA and our members look forward to working with FDA to ensure that there are appropriate balances with regulatory oversight necessary to ensure patient access to safe and effective medical devices while encouraging product innovation."