510K and Changes to Verification and Validation

DonkeyKang

Starting to get Involved
#1
I want to apologize in advance if I am missing an obvious point here. I am losing a little bit of perspective trying to see the big picture but constantly being wrapped up in minutia.

My company has a 510k cleared Class II device. This device was cleared about 2 years ago and no units sold yet. The have been focusing on improvements and resubmitting for a new device since, but just recently (last week) have decided that they want to sell the old 510k cleared units asap. They have also determined that the verification/validation of that original device was not up to par, so they are planning on re-verifying and re-validating first, but keeping all design the same. My question is: can you change verification/validation methods for a 510k cleared device and not have to resubmit?

Thank you in advance.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
As long as the design (including labelling) and manufacturing have not changed relative to the cleared 510(k), it remains legal to introduce the device into US commerce, regardless of any other activities that occurred post-clearance.

Obviously, if post-clearance activities indicate a problem or a possible NC with the regulations, you need to reconsider.
 

duinyk

Involved In Discussions
#3
I have a related question.

Is process validation required before filling a 510k or can batch testing work for that, in this case it will be an aseptic filling process. Is it possible to file a 510k without a process validation in place?

Thanks
 
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