Just facing a confusable question:

Company A is an medical device OEM located in USA.
Company B is the subcontractor of this medical device located out of U.S.A.

To save the labor cost, A authorizes B to help them making and placing manufacturer label (with Company A logo and user manual) on device, and ship the labeled device to company A in USA.

1) Is there any regulation problem? Does FDA or custom officer regard company B (subcontractor) send medical device to USA without its own 510(k)? or they still regard the labeled device is non-medical device during the shipment to USA?

2) For custom, the labeled device will be regarded as module or completely finished device? If Company A will repacked the received device and put more extra accessories with it before commercial distribution in USA market, the device during shipment can be regarded as module? If so, how can we make custom know it is just module rather than finished medical device?

Thanks

…well, you have to have a documented processes or procedures detailing that these medical devices will still be processed after reaching Company A (and in spite of the fact that they were already labeled)… and I hope, your procedures also detailing of how you identify the finished products from these incoming semi-finished products…

...and you can probably give copy of that documented procedures to the custom (if they will require) to support your claim… or even invited them to see the actual process…

(a lot of European countries are now doing the same thing… majority of processes will be done in Asia, where cost of workforce is relatively low… and return them back to the mother company before releasing to the market…)

Welcome Luloo,

I'll leave the first part of your question regarding FDA requirements to other Covers who are experts in this area.

With regards to the part on customs requirement, be aware that customs is primarily involved or interested with taxation. I think laws and practices vary from country to country and over in my place, we will need to apply to customs for exemption of this nature (with details such as modules that you mentioned). Movement of your parts out will need to be recorded and tallied when they are moved back and you will be fully responsible for discrepancies. This is usually the job of the shipping department. You may have to pay a nominal tax which will be refunded when proof of the goods being shipped back is submitted.

Thanks for all your help.

The core question is how to ship labeled products to USA without any regulation during and after the international shipping.

Ioshua_sx1's answer to the question (1) probably solved the regulation problem after shipping the semi-finished medical products to company A. The suggestion can protect the company A, But the regulation during shipping is not touched.


Ioshua_sx1's answer to the question (2) gave a good idea, but if the procedure of how to convert the semi-finished products to complete finished products has business procedure, then how can the company A expose its detailed business information to custom, or even other competitors when the shipping box lost? If the further process to the semi-finished products by company A with a lot of work, then should we put a thick binder with each products during shipping?

Luloo

What you are proposing is that company A source a "component" from company B (located overseas) with an intent to "convert" it into a finished medical device for which company A has a 510K.

Let me provide you with quick definition of terms here :
a. 21CFR820.3 (c) defines a component as "any raw material, piece, part, software, firmware, labeling or assembly which is intended to be included as a part of finished, packaged and labeled device.
Procuring "components" from suppliers is absolutely acceptable within CFR.

b. You are also proposing outsourcing of a process (assembly and labeling) to an outside supplier. I would strenously urge you to review a fantastic guidance document on this : Outsourcing, ISO13485:2003, Maintaining Control Of Outsourced Processes, (MDDI Archive, August 06.)mht
This document will provide you with a roadmap on how to design, implement, control, document and monitor this outsourcing.

I would additionally recommend that Company A (owner of 510K) file an amendment to the 510K to document this change. The CDRH decision tree on when to file amendment pretty much mandates this since labeling is involved.

Also, I would redraft the contract between the two companies to clearly identify this function and the steps you would take to maintain control and compliance. Easiest way to do this is to ensure that your supplier is in compliance with 21CFR820 QSR and this is verified by an independent auditor. Alternatively, if your supplier is ISO 13485 certified, it may serve the same purpose. Remember that component manufacturers are not required to register with the FDA.

Your flow processes, supplier evaluations must incorporate this change. Additionally, your risk analysis (FMEA) should incorporate this as a risk and the processes that you will put in place to monitor and minimize it.

Finally, the case labeling should clearly state that this is a component requiring further "processing" or some verbage to that effect.

I got a little winded there; the short answer is yes; you should not have a problem with this; however, you need to complete your preparatory work prior to that.