Medical Device Relabeler Obligations

R

Reinheitsgebot

As a relabeler of a device which is 510k cleared by the original equipment manufacturer, am I right in thinking that in order to market the device in the US I would simply be required to update my FDA listing to include the relabeled device? - i.e. there are no other obligations that the relabeler has to fulfil in order to legally market the product?

NB This is on the premise that I already have FDA establishment registration.

Many thanks for any advice!
 
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M

ManTheDan88

A Relabeler defined by the FDA is someone who:

Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

If you are not altering the product in any way and are only adding your own name than listing the product under the OEM's 510k number should be sufficient. Here's the link from the FDA website that lists out the requirements on who must register, list, and pay fees: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm#relabeler
 

Ronen E

Problem Solver
Moderator
If they are "not altering the product in any way and are only adding their own name" they're not deemed a relabeler.

If they are really a relabeler, I would start (broken link removed).

Cheers,
Ronen.
 
R

Reinheitsgebot

Thank you both for your replies and information, the scenario I envisage would certainly be relabeling as the OEM's devices would be purchased by the second comapny and packed in their branded packaging which has no reference to the OEM's brand.

In this case, I assume from what I understand so far that the only requirement on the second company is for them to update their FDA product listing?

The second company may also carry out a repackaging activity for some product configurations where the OEM's devices are packed in kit packs that also include the second company's own in-house manufactured products to make what you might call a 'procedure pack' or 'system kit pack.'

For the repackaged products, my question would be what, if any, regulatory activities may be required of the second company under FDA regulations beyond updating their FDA product listing?

Many thanks again -
 

Ronen E

Problem Solver
Moderator
Repackaging and Relabeling are considered to be Manufacturing.

What needs to be done in a certain context depends on the specific device in question and its classification (as in its FDA ProCode).

What you're looking for is a (medical devices) regulatory outline for specific products - some people prepare such outlines for a living (as freelancers); If you carefully go through the FDA website you could probably do it yourself as well.
 
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R

Reinheitsgebot

I scrape a kind of living in medical device RA myself:tg:

I've already researched the FDA website and not found any requirements on relabelers beyond registering the establishment (the one in question holds its own pre-existing establishment registration), updating the product listing to include the relabeled product and paying the relevant fee for making the update.

Hence my questions here, does anyone know of any other potential requirements beyond the above - I'm not looking for the whole roadmap just an indication if anyone knows if relabelers might have to do some kind of additional product registration activity when the relabeled device is already 510k cleared? It almost seems too good to be true that the relabeler only has to update their product registration list but maybe that is the case.

I am more familiar with the EU MDD situation where the relabeller would typically apply their own CE-mark via 'own-brand labelling' which requires a Notified Body review for devices other than EU Class I.
 
M

ManTheDan88

Is the product CLIA Waived? If it is you will have to get the OEM to send a letter to the FDA indicating that the Second Company needs to be added to the CLIA Registration.
 

Ronen E

Problem Solver
Moderator
Why do you bring CLIA up? I didn't see any indication in the posts that the device is related to clinical laboratory testing.
 

Ronen E

Problem Solver
Moderator
I scrape a kind of living in medical device RA myself:tg:

I've already researched the FDA website and not found any requirements on relabelers beyond registering the establishment (the one in question holds its own pre-existing establishment registration), updating the product listing to include the relabeled product and paying the relevant fee for making the update.

Hence my questions here, does anyone know of any other potential requirements beyond the above - I'm not looking for the whole roadmap just an indication if anyone knows if relabelers might have to do some kind of additional product registration activity when the relabeled device is already 510k cleared? It almost seems too good to be true that the relabeler only has to update their product registration list but maybe that is the case.

I am more familiar with the EU MDD situation where the relabeller would typically apply their own CE-mark via 'own-brand labelling' which requires a Notified Body review for devices other than EU Class I.

Hi,

You keep not telling us what the device / kit are (fair enough), which makes it difficult to give useful answers. Moreover, I'm a bit confused - are we talking just about relabeling, or about repackaging too?

Not a road map:

Unless otherwise specifically exempted, all General Controls apply to all Manufacturers and all devices. Relabelers and Repackagers are Manufacturers. The QSR (cGMP) is a General control. Are all the discussed devices GMP exempt?

Regarding 510k: Suppose that the relabeler could tag along an existing 510k. A repackager of the same device would not have it that easy, becuase changing the packaging might affect significant other characteristics of the device. The repackager would have to somehow show that it doesn't, if it doesn't. etc. etc.

The issue of 510k ownership, and of the use of an existing 510k (for listing purposes, for instance) by someone who is not the current 510k owner, has many nuances and is not always a straightforward one. I recommend you research the topic through reading the many threads we have here on that topic, or otherwise through published legislation and guidance (mostly on the FDA website).

Finally, Kit Packers / Kit Assemblers are sometimes subject to unique rules (different from those for "plain device" manufacturers).

My advice - if after fine-combing the FDA website you're still not sure what your regulatory action needs to include, hire a specialist. I have to ask you not to hire myself, otherwise this post would be self-promotion...

Cheers,
Ronen.
 
R

Reinheitsgebot

Thank you for the information, in terms of GMP the relabeler in the scenario is already FDA-registered for device manufacture and works to GMP so I assume there is nothing extra to do in this respect.

The FDA guidance here:

https://www.fda.gov/medicaldevices/...emarketsubmissions/premarketnotification510k/

- Quote from above:

"In most cases, if you are a repackager or a relabeler you are not required to submit a 510(k) if the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications."

- suggests that relabelers do not need to submit a 510k in a scenario where it is only the branding of the labelling that is being changed. This would apply to most of the products in the scenario I envisage, i.e. the relabeler is just going to put the OEM product in their own cartons, preserving all the necessary labelling information but with a different brand ID on the cartons.

I take your point about repackaging validation though, this could apply where the OEM's devices are being packed into system kits together with the second company's devices so I assume this could be case I guess where a new 510k is required.

Many thanks - RH
 
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