510K new manufacturer but same components

katiesam

Starting to get Involved
#1
Hello,
I am sending myself a little mad going round in circles here.
So.......we have come up against what I fear is a common issue; our contract manufacturers have decided that they fear the FDA too much and they don't wish to be listed with them anymore. They supply us with a class II device that has had 510K clearance for over two years but are yet to be audited.
The current contract manufacturer is happy to supply all of the components, so we would only need them finished, packaged and sterilised with new manufacturer (who is already listed with the FDA and has been audited many times).

I have three questions:

1) Am I right in thinking that in order to implement this change we would need to run new biocompatibility AND performance testing AND to submit a new 510K with the 'new device'?

2) We are concerned that there will now be a break in the supply chain whilst waiting for the above mentioned testing and 510K clearance; can our US distributor buy extra stock from us prior to the changes which can then be sold after the end of this year (if necessary) and before the new device has gained clearance? So our current contract manufacturer would not renew their listing for this next year but the device would have been manufactured whilst they were listed. Can the US distributor then sell the device in say January while we wait for the new product to gain clearance?

3) Have I mis-read the guidance and in fact we won't need a new 510K submission as the components of the device have remained the same?

Many thanks for taking the time to read this.

:) Katie
 
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shimonv

Trusted Information Resource
#2
Few thoughts:
It seems you are moving the final stages of manufacturing from one approved supplier to a new one. Of course, there are a lot of details involved such as new supplier qualification, work instructions, process qualification, revise pFMEA, and repeat some relevant validation activities.
BUT in essence - if the product specifications remains unchanged, you may not need to submit a new 510(k) application.

Have a look at FDA guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device".

Good luck,
Shimon
 

katiesam

Starting to get Involved
#3
Thank you for your response, I had a look at the guidance but because we are keeping everything the same materials wise and it is the manufacturer that has changed, who is putting the pieces together, packaging and sterilising I am left a bit confused.

I am presuming that biocomp testing will need to be re-done as the product is being finished in a different location, the same for the packaging and shelf life?
 

Rincewind

Involved In Discussions
#4
I don't see why a new Biocomp would be needed if everything stays the same (it might be needed if there are other changes like different processing aids or such).
 

monoj mon

Involved In Discussions
#6
3) Have I mis-read the guidance and in fact we won't need a new 510K submission as the components of the device have remained the same?
This flowchart is from the FDA Guidance (of course I re-do it for my personal use where I put my justification beside each "No"), and if all the answers to this flowchart is "No" in your case, then you don't need to submit a new 510(k).
1595579844725.png
 

katiesam

Starting to get Involved
#7
This flowchart is from the FDA Guidance (of course I re-do it for my personal use where I put my justification beside each "No"), and if all the answers to this flowchart is "No" in your case, then you don't need to submit a new 510(k).
View attachment 27017
Thank you for your response. So a change in the manufacturer will also mean a change in the packaging and steriliser, which could affect the biocompatibility of the product, so surely that comes under flow chart B, B3.2? If the new packaging and steriliser are already used by FDA cleared devices and the SAL is lower etc then I can say 'No' to B3.2 and B4.1?
 
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