510 (k) - Requirement to notify the FDA or is only the Notified Bodies required?

K

KimmyTn

#1
I need help looking for guidance relates to subcontract manufacturing.

We will be shipping sub-assembly devices to a subcontractor OUS and they will complete the device assembly and send it to our current sterilizer. We will receive the product back post-sterilization and will kit the work order here in the US. At this stage, is there any requirement to notify the FDA or is only the Notified Bodies required?

As planned, by the end of Oct 2015 the Contract manufacturer will take over the whole processes, order supplies, and complete the finish device assembly, ship to Sterilizer. We will kit the work order. At this stage, we will be required to submit 510k due to change in manufacturing location. My question what is the timeline to submit a 510k? When is the time to file a 510k? Is it going to be a 30 days 510k (Special 510k?) Thank you.
 
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M

MIREGMGR

#2
I don't think we know enough from your post to respond.

It may matter what the product is, what the original 510(k) said about suppliers, what processes are involved, the risk involved in the product's intended use, any validated processes involved, and so forth.
 
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