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

P

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.
 
Ronen E

Ronen E

Problem Solver
Staff member
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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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