Medical Device Establishment Registration/Listing for Foreign Private Labeler

[Qwer1234]

Hello,

I have a question relating to requirements for device establishment registration and listings for a foreign private labeler utilizing a foreign contract manufacturer.

The private labeler is looking to distribute a Class II product in the US that has a current 510(k) through the manufacturer (another foreign establishment). All that is changing is the product name.

It is my understanding that they will need to register as the specification developer, and list the device under their trade name using the manufacturer's 510(k) # for the device. (and designate a US agent since they are a foreign facility). Does that sound about right?

Thanks for any help!

 

[JeantheBigone]

Unless the relabeler is really the specifications developer, they should register and list as exactly what they are, namely, a relabeler.

https://www.fda.gov/MedicalDevices/...urDevice/RegistrationandListing/ucm053165.htm

Other than that, I agree regarding the listing of the device under the relabeler's trade name using the 510(k)-number and of course designating a US Agent.

Good luck!

 

[pmccain47]

Thanks for the response - private label arrangements always confuse me. Are they still a relabeler if the contract manufacturer is applying the labeling under their brand name that they specify? They do not do any of the physical labeling operations themselves.

 

[JeantheBigone]

When the establishments are not in the US, it can get VERY confusing because of the requirement that somebody somewhere has to be the initial importer.

And actually, I may have "misspoken." If the only thing that is changing is that the establishment is adding their own name, they are not a relabeler. My understanding however is that if they are using their own trade name, they are a relabeler.

One additional factor to consider is the UDI requirements.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/

The relabeler would need to apply for a DI barcode and get a GUDID account, and enter the information into the database at such time as the device requires a UDI.

 

[pmccain47]

Haha, agreeing to help them out with UDI requirements was what got me here in the first place. Working our way backwards from there. Can't thank you enough for the helpful comments so far.

It turns out DRLM has an activity listing for "Foreign Private Label Distributor." Can't find a definition for it but that seems to fit the bill pretty well.

But you hit the nail on the head, I am now officially confused by the initial importer requirements. I probably need to get more details on their gameplan, but I believe they have a partner in their organization who is located in the US and will be responsible for taking first title to the devices.

It looks like they also need to register. But can they do that under the same FURLS account as just a second US establishment? Will they need to pay a separate user fee? Any more thoughts would be greatly appreciated.

 

[JeantheBigone]

There are initial importer requirements according to FDA, which are minor, and then there are expectations of the foreign manufacturer, which may be different.

And by an interesting coincidence, I received a phone call yesterday from an FDA inspector wishing to inspect an initial importer of one of my foreign clients. I'll be curious to see how this shakes out.

The rule regarding FURLS accounts is each address needs its own account. Each account pays its own user fee. Whoever registers as the manufacturer should make sure they comply with the FDA QSR system because after two years at the latest they will be inspected by FDA.

One single foreign entity can be the Specification Developer, Manufacturer, and Foreign Exporter, and one single domestic entity can be the Initial Importer and Relabeler, but the key is, one address, one registration.

Be careful, sometimes when push comes to shove, someone attempts to muddy the waters and claim that one of the other parties is responsible for recording keeping and reporting activities. FDA makes their expectations know in the regulations. Whatever goes on between the business entities needs to be in a written contract. For example, FDA does not clearly regulate who is responsible for fulfilling UDI in cases where there is a private label, all they care about is that somebody handle it.

 

[Ronen E]

because after two years at the latest they will be inspected by FDA.

This is true in theory, maybe. With foreign manufacturers, I've seen cases where they were not inspected by the FDA for ~10 years. It's a matter of risk level and FDA priorities.

I would phrase it the other way around: Before 2 years have gone by, FDA won't show up unless it's a for-cause inspection. After 2 years, they might, according to their own schedule.

 

[JeantheBigone]

I agree that FDA won't come knocking before two years unless it is for cause, but lately they have been coming just about when the two years were up for my clients, and it none of the inspections was for cause.

It's probably worth noting that under some circumstances, FDA will accept a third party inspection in lieu of the FDA inspection. Details are here:

(broken link removed)

I have no experience with this so I can't offer any first hand comments.

I bring up the inspection issue because often non-US establishments falsely believe that being ISO 13485 accredited will help them with FDA QSR. It won't. They usually get tripped up by the FDA CAPA requirements.

 

[Ronen E]

I agree that FDA won't come knocking before two years unless it is for cause, but lately they have been coming just about when the two years were up for my clients, and it none of the inspections was for cause.

Again, it's a matter of risk, both device risk and (believe it or not) perceived risk to the inspectors. In some regions and periods manufacturers aren't being inspected simply because there is a current travel warning issued by the US government.

If, for whatever reason, the device is considered low risk / low interest according to current FDA thinking it may be well over 2 years before they come in.

I do agree that this is not something that can be counted on, though.

I bring up the inspection issue because often non-US establishments falsely believe that being ISO 13485 accredited will help them with FDA QSR. It won't. They usually get tripped up by the FDA CAPA requirements.

I think that this kind of thinking might be a result of the VARSP program (now ended) where voluntary submission of ISO 13485 audit reports could have led to further (significant) postponement of FDA establishment inspections. Either way, this is now reincarnated in MDSAP, under which ISO 13485 audits and FDA inspections are supposedly unified.