Revise or to Not Design Input Document for On-Market Cleared Class II Device

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Silvertabb

#1
If you are faced with replacing certain parts for a class II FDA cleared device with equivalent ones due to parts no loger available or manufactured and you determine after the change impact assessment review of your design input documents that there is an impact to some noncritical requirements, is it wise to perform design verificaiton testing and provide justification for noncritical requirements that are not PASSING or to revise the design requirement document to update/remove the requirements that no longer apply or are not PASSING DVT?
 
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#2
If you are faced with replacing certain parts for a class II FDA cleared device with equivalent ones due to parts no loger available or manufactured and you determine after the change impact assessment review of your design input documents that there is an impact to some noncritical requirements, is it wise to perform design verificaiton testing and provide justification for noncritical requirements that are not PASSING or to revise the design requirement document to update/remove the requirements that no longer apply or are not PASSING DVT?
If they are noncritical and you have justification why it is not important that they be met (actually that would be justification why these requirements are not important, wouldn't it?) then I would say revise the Design Input document and capture the justifications in its revision history.
 
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