About the 510(k) Submission US Company but Products are made in China

I

ivybell

#1
We have a company in U.S. , but our products are made in China,
If We want to submit a 510(k), can we use the U.S. company name to submit a 510(k)and as a holder of this 510(k)?
If we don't need to include the manufacture (the China facility) information in our labels, Is that OK?

Are there any related regulation in FDA website?
 
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Ronen E

Problem Solver
Moderator
#2
Re: About the 510(k) Submission

We have a company in U.S. , but our products are made in China,
If We want to submit a 510(k), can we use the U.S. company name to submit a 510(k)and as a holder of this 510(k)?
If we don't need to include the manufacture (the China facility) information in our labels, Is that OK?

Are there any related regulation in FDA website?
Hi,

I can't see a problem with your US company being the 510(k) owner and/or being the legal manufacturer in the labeling. The latter would mean the US company will bear the applicable regulatory responsibility towards the FDA. The manufacturing plant in China would, in that setting, be a foreign contract manufacturer shipping finished devices into the USA, and as such have registration (and associated) obligations as specified in 21 CFR.

Cheers,
Ronen.
 
I

ivybell

#3
Re: About the 510(k) Submission

Ronen,Thank you for your help.

As a foreign contract manufacturer, Is the China company required to register in FDA?
 
I

ivybell

#5
FDA reply:

Question 1: If We want to submit a 510(k), can we use the U.S. company name to submit a 510(k)and as a holder of this 510(k)?

Answer: The Us firm can sponsor the 510(k,) they then have ownership of the 510(k)and have final responsibly for the device, that would include the labeling

Question 2: If we don't need to include the manufacture (the China facility) information in our labels, Is that OK?

Answer: The manufacturer in China is a contract manufacturer and would not be responsible for that.
 

Ronen E

Problem Solver
Moderator
#6
FDA reply:

Question 1: If We want to submit a 510(k), can we use the U.S. company name to submit a 510(k)and as a holder of this 510(k)?

Answer: The Us firm can sponsor the 510(k,) they then have ownership of the 510(k)and have final responsibly for the device, that would include the labeling

Question 2: If we don't need to include the manufacture (the China facility) information in our labels, Is that OK?

Answer: The manufacturer in China is a contract manufacturer and would not be responsible for that.
Thanks for sharing, I believe this accords with my previous posts. In "would not be responsible for that" I believe the FDA referred to the inclusion of the China facility information in the labels (not required); a foreign contract manufacturer is nevertheless required to register and list if they ship finished devices into the USA.

Cheers,
Ronen.
 
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