Regulation of Medical Devices in the United States and European Union

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pkost

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#2
Interesting article - certainly one of the more accurate ones written by medical professionals. Shame it didn't really say anything new.
 
L

lfrost

#3
I agree with the article being interesting, however, it only addresses medical devices that in the US are classified as Class III. Class II devices are also ones that must be proven to be safe and effective by the manufacturer albeit that all class II devices do not need to be put through PMA by the US FDA. This becomes very confusing for manufacturers who will just distribute their devices without registering their devices with the US FDA. A simple process really, when compared to the alternative.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
I agree with the article being interesting, however, it only addresses medical devices that in the US are classified as Class III. Class II devices are also ones that must be proven to be safe and effective by the manufacturer albeit that all class II devices do not need to be put through PMA by the US FDA. This becomes very confusing for manufacturers who will just distribute their devices without registering their devices with the US FDA. A simple process really, when compared to the alternative.
Sorry if it sounds petty, but actually Class II devices are not directly required "to be proven to be safe and effective by the manufacturer". They are required (except those that are 510k exempt) to be "substantially equivalent" with a legally marketed device (such equivalence may be substantiated, for instance, by showing that the intended use and the technological characteristics are the same). Indeed, in many cases such equivalence would presumably indicate safety and effectiveness.
 
L

lfrost

#6
Sorry if it sounds petty, but actually Class II devices are not directly required "to be proven to be safe and effective by the manufacturer". They are required (except those that are 510k exempt) to be "substantially equivalent" with a legally marketed device (such equivalence may be substantiated, for instance, by showing that the intended use and the technological characteristics are the same). Indeed, in many cases such equivalence would presumably indicate safety and effectiveness.
RonenE,

You are correct, thank you for setting me straight on something that I knew, but left out of my reply.
 
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