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After stumbling on this thread by accident, I came across a PP presentation from FDA regarding Global Hatrmonization, specifically EN 60601-1 recognition, more specifically EN 62304 compliance. Bottom line - although FDA does not yet recognize 60601-1, they clearly intend to do so. However, if one is selling to Europe and is ISO 13485 certified AND voluntarily claiming compliance to 60601-1 (as are we), compliance with EN 62304 is mandatory (see slide #11 of the attached FDA presentation).
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