FDA and Customs Label Conflict

[sj_vr6]

To start, I've been a longtime lurker and found Elsmar Cove to be an extremely useful reference. Now, I'm up against a challenge I hope some of you folks can chime in on...

As background, we are Class II device specification provider in the US with our primary contract manufacturer in a different country. The 510k for the device is in our name, and we hold all regulatory responsibilities for the device.

The FDA is holding a shipment of product and is requiring we update the labeling. The labeling has our name as the manufacturer and lists our contact information as required by 21CFR801.1, and also includes the "Assembled in [foreign country] from US components" statement to satisfy Customs requirements. The FDA personnel say we need to have "Manufactured for" in front of our company's name to resolve the conflict between our business address and the "Assembled in..." declaration.

I cannot find reference that this perceived conflict is noncompliant, and think what they are requesting is incorrect as it implies we are not the 'manufacturer' from FDA's perspective (legal person who assumes regulatory responsibility for the device). Am I right in this? If yes, what is the best approach to prove this/educate the FDA personnel at the border in short order so the shipment can be released?

Thanks in advance!

 

[Ronen E]

To start, I've been a longtime lurker and found Elsmar Cove to be an extremely useful reference. Now, I'm up against a challenge I hope some of you folks can chime in on...

As background, we are Class II device specification provider in the US with our primary contract manufacturer in a different country. The 510k for the device is in our name, and we hold all regulatory responsibilities for the device.

The FDA is holding a shipment of product and is requiring we update the labeling. The labeling has our name as the manufacturer and lists our contact information as required by 21CFR801.1, and also includes the "Assembled in [foreign country] from US components" statement to satisfy Customs requirements. The FDA personnel say we need to have "Manufactured for" in front of our company's name to resolve the conflict between our business address and the "Assembled in..." declaration.

I cannot find reference that this perceived conflict is noncompliant, and think what they are requesting is incorrect as it implies we are not the 'manufacturer' from FDA's perspective (legal person who assumes regulatory responsibility for the device). Am I right in this? If yes, what is the best approach to prove this/educate the FDA personnel at the border in short order so the shipment can be released?

Thanks in advance!

Hello and welcome to posting

I believe you are right. However, I don't think that there's a quick way to resolve this with the FDA personnel at the border. I think you need to address this to a higher FDA instance who will either issue you an official letter which you'll be able to present to the border staff, or sort it out directly with them (preferably with some doc track to you, for next time). I'm not sure who is best to approach in the FDA, though. Maybe the Office of Compliance, or DICE?

Cheers,
Ronen.

 

[Access2hc]

Put it this way.. if you read what's being asked.


Assembled in [foreign country] from US components, in [foreign country address], "Manufactured for" [your company] - the legal manufacturer [your address] of [product]

Does it make sense to you?

I believe they are after the fact that a substantial proportion of the device was made outside of the US, which means can't claim made in the US, in which FDA Is trying to help to reconcile for you to make things sound consistent.

 

[MIREGMGR]

I believe they are after the fact that a substantial proportion of the device was made outside of the US, which means can't claim made in the US, in which FDA Is trying to help to reconcile for you to make things sound consistent.

I think the statement quoted directly above is an incorrect regulatory analysis. It is common practice for a US device establishment to be the regulatorily responsible Specification Provider (in effect, Manufacturer) of a device that is physically made by a contract manufacturer located outside USA. In this case, the labeling must indicate both the required FDA information, and the required information under the Customs & Border Protection (CBP, part of Department of Commerce) rules regarding declaration of national origin. It's well understood that these are two distinct rule-sets, and that they have different, arguably conflicting requirements because they exist to satisfy different regulatory needs. So, you follow each of them by means of the expected statement in the expected format, and everyone understands.

Regarding the original post, it's not normal for FDA and CBP personnel to be confused about such very basic issues. Clearly the responsible party for a device can be identified by looking at the two associated Listings (one by the Specification Provider, the other by the contract manufacturer), which takes all of ten seconds. Clearly if the responsible party is the described US company, a "Manufactured For" statement per 21CFR 801.1 would be regulatorily wrong. I'm wondering if there's some detail to the wording or graphical presentation of the labeling in question, or some discrepancy in the two necessary Listings, that is causing the confusion.

 

[sj_vr6]

Thanks for the responses.

I too was thinking of obtaining an authoritative statement that our labeling is appropriate, and then presenting it if questioned by the folks at the border. I will consider reaching out to the Office of Compliance, DICE, and ORA.

Also, the inspector is categorizing our goods coming into the US as 'imported finished medical devices'. Is there a regulation or guidance that clarifies that fully processed and final commercial configurations coming across the border from a contract manufacturer to a specification provider is a different scenario than devices manufactured abroad by the FDA regulatorily responsible party being shipped to the US for commercial distribution?

Thanks again!

 

[MIREGMGR]

Also, the inspector is categorizing our goods coming into the US as 'imported finished medical devices'.

If they're Listed as being made by a contract manufacturer, and if at time of importation they are substantially ready to be used in a medical procedure, not considering packaging, labeling and/or sterilization, then that's correct. By definition, Contract Manufacturers make finished medical devices. If they were unfinished when imported, the offshore fabricator would be a 21CFR 807.65(a) component maker, not a contract manufacturer, and the product could not be listed as being contract manufactured by that component maker.

Is there a regulation or guidance that clarifies that fully processed and final commercial configurations coming across the border from a contract manufacturer to a specification provider is a different scenario than devices manufactured abroad by the FDA regulatorily responsible party being shipped to the US for commercial distribution?

No, there isn't. It isn't a "different scenario" in the sense that you want it to be.

 

[sj_vr6]

OK, makes sense - no distinction between scenarios.

So, since we are importing finished medical devices, is our company the Device Initial Importer (even though we are the manufacturer and legally responsible party for those devices)?
I interpret the definition for the DII as an entity that "...furthers the marketing of a device from a foreign manufacturer..." as not applicable because we are not intending to further market the devices (we will initiate marketing) and our foreign contract manufacturer is not a 'manufacturer' from the FDA's perspective.

 

[J0anne]

The name and address of the manufacturer is a requirement
and the rest follows:

'801.1 (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.'

 

[MIREGMGR]

The name and address of the manufacturer is a requirement
and the rest follows:

'801.1 (c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.'

We of course know from experience that FDA cannot be relied upon to be consistent in regard to significant terminology...but historically, they have (usually) used "manufactured" to indicate the party that is regulatorily responsible for the fabrication of the product, whether or not that is the party that physically fabricates the product. In that regard, a Specification Developer is a Manufacturer, and in any relationship involving contract manufacturing, the resulting device has at least two manufacturers.

The definition of "Manufacturer" on the Who Must Register and List page is abbreviated. A complete definition is at 21CFR 803.3:

Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:

(1) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;

(2) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;

(3) Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or

(4) Is the U.S. agent of a foreign manufacturer.

Note that this definition is slightly more broad than the one in 21CFR 807.3.

My understanding, and certainly my observation of industry practice, has been that the wording of 21CFR 801.1 was chosen primarily to provide for the "private labeling" exemption, in which a product may be marketed with no identification of the responsible Manufacturer on the label and instead only identification of the product's distributor for which the product is Private Labeled, if the label states immediately above the name of that distributor either "Manufactured For" or "Distributed By".

 

[MIREGMGR]

OK, makes sense - no distinction between scenarios.

So, since we are importing finished medical devices, is our company the Device Initial Importer (even though we are the manufacturer and legally responsible party for those devices)?
I interpret the definition for the DII as an entity that "...furthers the marketing of a device from a foreign manufacturer..." as not applicable because we are not intending to further market the devices (we will initiate marketing) and our foreign contract manufacturer is not a 'manufacturer' from the FDA's perspective.

Actually contract manufacturers do meet the definition of "manufacturer".

My understanding of your proper action would be to List as Specification Developer and Initial Importer. Your CM then would List in that CM role.