As originally asked by Sabine K.

Manufacturer A owns a 510(k) and is a contract manufacturer (OEM) for company B.
B wants the product lets say in pink instead of yellow and packaged with its own IFU and in the name of B.
Is it possible for B to import and sell this product in the US referencing the 510(k) of A?

Do you know similar cases? What is your experience? Any advice or appropriate link is highly appreciated.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Sorry Jean, I don’t know. Hopefully someone else on the list can let you know.

Jean Bigoney, RAC, CQE
Regulatory Affairs Specialist.
Derek I am curious if it is necessary to update the file to include a new distributor or if this information is now covered by updates to the FURLS (Registration and Listing) system where this information is entered by both manufacturer (510(k)-holder) and distributor.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Sabine,

Distributors cannot “use their own IFU” since the manufacturer that owns the 510k is responsible for the IFU and they must keep all the documentation related to the device listing up to date (including changes to the IFU.) As the distributor you may design, print and provide the IFU but it is still the responsibility of the 510k holder and they must approve it and ensure it complies with their listing and document the changes.

If you want to see when a new 510k is required, the FDA website has a guideline K97-1. The FDA website is an excellent resource and easy to navigate. regards, Derek

Sabine K.
Senior Scientific Expert bei Dr. Regenold GmbH
Hi Derek and Rosa,
many thanks for your advice. I learned that:
My manufacturer and owner of the 510(k) should be an FDA registered establishment, is responsible for the documentation, but may assign distributors. They can use their own IFU but must include a “distributed by” (correct?). If they make major changes they need their own 510(k).
Regards,
Sabine

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Yes, but the 510k owner must agree and continue the regulatory role (including updating the file to indicate the new distributor on the IFU.) I assume you are already an FDA registered establishment and the device is already listed as manufactured by you.
cheers, derek

Rosa Deng
International Sales Director at Foryou Medical Devices Co.,Ltd.
Hi Derek,
Thank you.

It seems, either the manufacturer or the distributor ows a 510K can market product in the US, right?

Frank and Anna wish you a big success with your special product. Alvin was resigned two years ago.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Hi Rosa,

The holder of the 510k is responsible for placing the product on the market and for maintaining the documentation but they may assign distributors (ie. “Distributed by…”.) You can license or buy the 510k from the current holder but only one company can manufacture the device so a license would have to be exclusive (and the licensor could not also manufacture the device.)

Say Hello to Frank, Anna and Alvin for me if they are still with Foryou.

Rosa Deng
International Sales Director at Foryou Medical Devices Co.,Ltd.
If company B owns a 510(k), company A, the manufacturer does not have a 510K. Is it possible to market the product in the US. Company B located in the US, company A outside of US.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Your manufacturer would update their FDA device listing with a “letter to file” for the changes (branding, “distributed by..” etc.)

Elizabeth Nichols
Sr. Compliance Auditor at Abbott Laboratories
You can see examples of this any time that you go to a grocery store or pharmacy that has a “store brand”. As far as I am aware, that pharmacy chain would not own a regulatory filing for their store brand product. The manufacturer of the product owns the regulatory filing, and they provide the regulatory agency with the labeling, including the IFU for the product variations.

As noted above, the IFU must match the regulatory filing, so you wouldn’t be able to make any changes. It would need to stay in alignment with the regulatory filing. The only difference would be the product “store brand” name. All the details on responsibilities need to be worked out between the two companies.

Derek White
Innovative Manager in Strategy, Operations, Purchasing, Project Management, International MBA, MSc in Innovation.
Hi Sabine,
Usually it is the other way around with the marketing company (“specification developer” to the FDA) holding the 510k and being responsible for placing the product on the US market and maintaining all the documentation.

In your scenario you can either request the manufacturer to do a pink version for you with your IFU, branding etc. but they would still be the responsible manufacturer and their name would need to be on the IFU. If you remove their name or make major changes to the IFU (eg change intended use, warnings, contraindications etc) you would then need a 510k. Simply adding your name and not making major changes would not require a new 510k.

For strategic reasons I would recommend getting your own 510k eventually. It will give you more flexibility and leverage with your supplier(s) and the additional documentation and scrutiny should be relatively easy for Sutter.
I hope this helps, Derek