H
Well yeah I have been misinformed :mg:
But there still is a problem, let me rephrase...
We want to market an emergency and transport ventilator in the USA and therefore we need to submit a premarket notification with the FDA. There are a couple of guidance documents available that we intend to use:
-The draft reviewer guidance for ventilators (1995)
-The draft reviewer guidance for premarket notification submissions (1993)
These guidance documents refer to several standards, e.g. ASTMF1100-90 (1997) (withdrawn and replaced by ANS/IEC60601-2-12) and ASTMF1246-91(1999), none of which apply for emergency and transport ventilators..
I am wondering what to do here...
Should we refer to a standard that does appy (e.g. ISO10651-3 (CAN/CSA) or EN794-3) or is there another standard??
But there still is a problem, let me rephrase...
We want to market an emergency and transport ventilator in the USA and therefore we need to submit a premarket notification with the FDA. There are a couple of guidance documents available that we intend to use:
-The draft reviewer guidance for ventilators (1995)
-The draft reviewer guidance for premarket notification submissions (1993)
These guidance documents refer to several standards, e.g. ASTMF1100-90 (1997) (withdrawn and replaced by ANS/IEC60601-2-12) and ASTMF1246-91(1999), none of which apply for emergency and transport ventilators..
I am wondering what to do here...
Should we refer to a standard that does appy (e.g. ISO10651-3 (CAN/CSA) or EN794-3) or is there another standard??
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