Traditional 510k Filing SOP (Standard Operating Procedure)

S

Silvertabb

#1
Dear all,
Is it required to file 510k electronically?
Does anyone have a SOP or procedure for traditional 510k filing for IVD they can share?

Thanks in advance for your help.
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Traditional 510k Filing SOP

Dear all,
Is it required to file 510k electronically?
Does anyone have a SOP or procedure for traditional 510k filing for IVD they can share?

Thanks in advance for your help.
Hi and welcome to the cove :bigwave:

Sometimes there are specific guidance documents for specific types of devices. It is recommended to classifiy your device first and then see whether there's a 510(k) guidance document associated with your specific product code. If not (and your device is not exempt), the general traditional 510(k) guidance document would be a good starting point.

Cheers,
Ronen.
 
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