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Reporting a Change of Contract Manufacturer for a 510(k) cleared device

KMac

Registered
#1
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
 

Ronen E

Problem Solver
Staff member
Moderator
#2
Strictly speaking, your analysis may be correct. BTW, that PMA-related guidance may be very useful for you in deciding what else (i.e. not 510k-related) you need to do. It's a good guidance nonetheless.

Now, given that it's an implant of probably a higher-risk (IIb is not an FDA classification), I would consider approaching the FDA cautiously to probe whether they would, actually, expect a Special 510k. Maybe the pre-sub route would be appropriate, you'd have to research a bit and consider your options (and risks).
 

KMac

Registered
#3
Strictly speaking, your analysis may be correct. BTW, that PMA-related guidance may be very useful for you in deciding what else (i.e. not 510k-related) you need to do. It's a good guidance nonetheless.

Now, given that it's an implant of probably a higher-risk (IIb is not an FDA classification), I would consider approaching the FDA cautiously to probe whether they would, actually, expect a Special 510k. Maybe the pre-sub route would be appropriate, you'd have to research a bit and consider your options (and risks).
Thank you for your response Ronen. That's was my slip up, the implant is a Class 2 device under the FDA classification, but your cautionary advice still remains.

That was indeed my next step, to engage the FDA directly for some guidance. I will keep researching for now to see if I can find any evidence of this situation and steps to take.

I am still open to anyones experience in relation to a similar situation though.

thanks again
 

katiesam

Starting to get Involved
#4
Hello, I was wondering you had found your answer? We are possibly looking for a new contract manufacturer for our 510K cleared device but wondering how we go about this as far as the FDA is concerned.
 
#6
Maybe it's just me, but I would expect any medical device contract manufacturer to have this information at its fingertips. I wouldn't expect them to advise a client regarding what is required in the client's specific situation, but to know what regulations apply and what guidances are available, and where the client can find the information, yes. If that's not common in the industry.....well, there is a competitive edge just waiting to happen, IMO.
 
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