Hi,
Our company is in the process of changing contract manufacturers of a 510(k) cleared Class IIb implant and I was looking for some guidance as to how we would notify the FDA of this change.
Our company, the original CM and any potential new CMs are located outside of the US, so I assume we all need to be registered and list the device.
What I can't find is any information about requirements for notifying the FDA of this change, outside of changing the listing information on FURLS. I was a little worried it might trigger a new 510(k) but after combing through the "Deciding When to Submit.." guidance doc, and without the manufacturing process actually changing, I can't see any solid evidence that this would be the case.
There is a new guidance document that outlines this type of change for PMA and HDE, but it specifically says it doesn't cover 510(k)s so never mind about that I guess.
If anyone has any information or experience with this situation I would be very grateful to hear it.
Thank you
Our company is in the process of changing contract manufacturers of a 510(k) cleared Class IIb implant and I was looking for some guidance as to how we would notify the FDA of this change.
Our company, the original CM and any potential new CMs are located outside of the US, so I assume we all need to be registered and list the device.
What I can't find is any information about requirements for notifying the FDA of this change, outside of changing the listing information on FURLS. I was a little worried it might trigger a new 510(k) but after combing through the "Deciding When to Submit.." guidance doc, and without the manufacturing process actually changing, I can't see any solid evidence that this would be the case.
There is a new guidance document that outlines this type of change for PMA and HDE, but it specifically says it doesn't cover 510(k)s so never mind about that I guess.
If anyone has any information or experience with this situation I would be very grateful to hear it.
Thank you