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Parallel processing IEC 60601 testing and 510k submission

M

medgar

#1
Hi

I am somewhat new to the FDA regulatory processes and history.

I am looking to put in a 510k for a class 2 EEE. It requres 60601-1 etc.

My reading of the current guidelines is that I will need to make a declaration that all the relevant electrical safety testing has been completed and the device has successfully passed. => to do this, the testing needs to be done before the 510k submission.

A colleague has approached me and indicated that previously, the FDA has accepted and approved 510k submission which have indicated that the '60601 testing is underway and the company gives the assurance that the product will not be placed on the market until the testing has been finalised and the product has past'.

The result of this was the ability to parallel process the 60601 testing and the 510k process thereby bringing the product to market quicker.

Can anyone shed some light on whether:
1. This used to be the case but the current FDA guidelines don't allow it

2. This is still the case and I have read the current FDA guidelines a too literally (parallel processing still OK).

Thanks
 
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