🔥 Find me at MedicalDevicesGroup.net 🔥
< 1 min reading time
As originally asked by Sabine K.
Manufacturer A owns a 510(k) and is a contract manufacturer (OEM) for company B.
Do you know similar cases? What is your experience? Any advice or appropriate link is highly appreciated.
Jean Bigoney, RAC, CQE
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
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.
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.
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.
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.
Marked as spam