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FDA's deadline for IEC 60601-1 3.1 edition compliance - Aug 1, 2016

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Phloogy

#1
#1
FDA's deadline for 60601-1 3.1 ed compliance is Aug 1, 2016. What are the impacts for not meeting that deadline? Can we still ship commercialized product that is 3.0 compliant but not 3.1? Thanks in advance.
 
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Ronen E

Ronen E

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#2
#2
In the US regulatory system, generally there's no requirement to keep with the State of the Art. If by "commercialised" you mean that a device model has already been cleared (eg 510(k)) and legally sold in the US, no further edition upgrades are required as long as the design is not changed (unless a specific requirement has been issued by the FDA). Only submissions occurring after the switch over date are required to meet the new edition.
 
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