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510k with Contract Manufacturer

H

HH0312

Registered
#1
#1
Hello! I have a regulatory question and I am finding mixed answers as I am reading through the available guidances and forums.

Current Situation:
Company A is the 510k owner and manufacturer of device 'X' which is provided solely to Company B for commerical distribution. Company A has complete ownership of the DHF, DMR, and completes all packaging, sterilization, and labeling with their information prior to shipping to Company B for distribution. Company B does nothing other than distribute the device and they are the sole distributors of device 'X'.

Now, Company A has asked Company B to submit a new 510k for device 'X'. Important to note this is NOT a transfer/sale of a 510k. Company A still wants to own their 510k for manufacturing other devices. The new 510k to be submitted by Company B will use Company A's 510k as SE. The new 510k will allow Company A to become the owner and liable for device 'X'. Company B will continue to use Company B as the contract manufacturer of device 'X' including packaging and sterilization. Labelling will be changed to Company A as the now owner of device 'X'.

My question is, as Company B, what do I need to include in the submission? I do know that we will be responsible for the DHF and DMR and Company A is happy to give all documentation to support the new 510k and transfer of liability. Company A will also update their registeration as a contract manufacturer and contract sterilizer. Other than that, just follow the traditional 510k outline and call it a day?

Thank you for your help!
 
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M

monoj mon

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#2
#2
Your question is little bit confusing to me. The following are my confusions,
1.
HH0312 said:
The new 510k will allow Company A to become the owner and liable for device 'X'
Click to expand...
Isn't the Company A already the owner of the 510k as well as the device? As you have said here
HH0312 said:
Company A is the 510k owner and manufacturer of device 'X
Click to expand...
2.
HH0312 said:
Company B will continue to use Company B as the contract manufacturer of device 'X'
Click to expand...
How can you use your own company as the contract manufacturer of the device that you distribute?

3.
HH0312 said:
Company A still wants to own their 510k for manufacturing other devices.
Click to expand...
What do you mean by "manufacturing other devices'? Do you mean the same device 'x' to be distributed by other companies! Or they want to manufacture other models of the same device 'X'! Or they want to manufacture totally different devices based on the existing 510(k)! If second or third case is true then I doubt there is a big misunderstanding from Company A regarding how the 510(k)s are to be used.

Overall (with all the confusions which I assume as typo from your side) what I understood is that, Company A wants you to be liable for the device 'X' and wants 'Company B' to be the owner of a new 510(k) for the said device. If this is the case and nothing has been changed in the device, packaging, sterilization etc. then I guess you just simply follow the traditional 510(k) content based on FDA guidance. In your case, while preparing the summaries, I guess you should be able to refer the content of the former 510(k) since you haven't done anything new (but I am not sure about it).
 
H

HH0312

Registered
#3
#3
To address your questions, Company A's 510k is broad allowing for multiple SKUs. Device X is simply one of the SKUs Company A manufactures within the 510k clearance and is distributed exclusively by Company B. Company A wants to continue to hold their 510k in order to manufacture the other SKUs (aka devices Y, Z) and Company B will be liable and own a 510k exclusively for device X. Yes, typo in that Company B will continue to use Company A as the contract manufacturer of device 'X' after 510k clearance.

I agree with your assessment that since nothing changed to the device in terms of manufacturing, packaging, or sterilization, I should follow the traditional 510k FDA guidance. Thank you for your response and reassurance!
 
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