Importing a Registered Class II Device, the Applying Our Label - Need New 510(k)?

[MattRamsle]

My firm manufactures and distributes several of our own Class II medical devices. We would now like to import a class II device from an overseas manufacturer who is registered with the FDA and has a 510(k) for the device. We then want to relabel the product with our own label (with basic company name and item name information), and market the product as our own device. The overseas manufacturer is fine with this. But, would we need to get a 510(k) for the product, or just list it with our other device listings?

 

[Ronen E]

We then want to relabel the product with our own label (with basic company name and item name information), and market the product as our own device.

This statement needs to be clarified really well to allow unequivocal conclusions about your obligations. Which (if any) of the following statements are false?

- The old labelling will stay
- The actual manufacturer’s details - name, address, contacts, as well as the original item tradename, will be removed / avoided / covered in a reliable and durable way
- You will only add your company’s name, address & contacts, and your own item tradename
- You do not intend to use the “distributed by / manufactured for” clause in the labelling regulations
- Your company will take full regulatory responsibility for the device, including fulfilling any and all regulatory requirements that apply to a Manufacturer, for this device
- Your company has knowledge and expertise regarding the type of the device in question (application, technology, design etc.) that is not vastly inferior to that of the actual manufacturer

 

[MattRamsle]

Thanks for the reply. Much appreciated. Answers are below:

- The old labelling will stay - I just learned that this product will come in unlabeled. That should simplify things.
- The actual manufacturer’s details - name, address, contacts, as well as the original item tradename, will be removed / avoided / covered in a reliable and durable way - N/A since the product will arrive unlabeled.
- You will only add your company’s name, address & contacts, and your own item tradename - False. We will also add directions for use.

- You do not intend to use the “distributed by / manufactured for” clause in the labelling regulations - The label will state "Manufactured for" us.
- Your company will take full regulatory responsibility for the device, including fulfilling any and all regulatory requirements that apply to a Manufacturer, for this device - False. We intend to take on the regulatory responsibility for a relabeler in this case. Seems like the best fit when looking at the definitions for Initial Importer, Relabeler, etc...
- Your company has knowledge and expertise regarding the type of the device in question (application, technology, design etc.) that is not vastly inferior to that of the actual manufacturer - True. We have expertise in this area.

 

[Ronen E]

Thanks. One more question:

You noted “We will also add directions for use.” Are the new labelling contents going to be identical to the original’s (except company identification and device tradename)?

Added in edit: An interesting Elsmar thread that maybe useful for you.

 

[MattRamsle]

That's a good question. I just found out that they will come in without instructions, and that we will insert our own Direction For Use document.

After reading the other thread, and FDA's requirements, I feel comfortable listing the product in our FDA device listings, while noting the OEM's 510(k). I was wondering if we'd need to submit a new 510(k), but that does not appear to be the case.

Thanks for the help. Such a good resource.

 

[Oconster]

Re: Re-packager/Re-Labeler - FDA Registration question
I’ve read through here and I’ve got the understanding of where I think my company belongs, but here’s where I’m lost. We take a bulk pack device that is sold nonsterile and relabel it repackage it and sterilize it. We have a PLD agreement with the manufacturer and they know we do this. We import the device from Germany. The device was 510(k) approved for user sterilization (moist heat) and we are doing Gamma. What do we need to have in place to satisfy the FDa