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.
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