Regulatory Open Forum

According to general device labeling requirements, if the firm listed on the device label is not the manufacturer, the firm information must be qualified by an appropriate statement such as, "Manufactured for..." or "Distributed by...."

Is there a difference between the two in who is required to maintain the DHF for the device?

More specifically, if a firm purchases an item from another manufacturer to be included in a convenience kit and includes the statement "Manufactured for...." on the product label, who is required to maintain the DHF for the purchased product, the OEM or the firm placing the purchased item in their convenience kit?  Is it different if the label states "Distributed by...."?

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David Burtard
Rio WI
United States
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There seems to be a few aspects to this question. Presumably, you refer to §801.1(d) which includes this language. Your initial question is about the DHF, but I suspect it goes much deeper.

Let’s start with the simple case, before the convenience kit complication. The best starting point is the registration requirements, UCM053165, because it has a lot of good definitions.

The first relationship is Specification Developer and Contract Manufacturer. The Specification Developer defines the device while the Contract Manufacturer makes it. If it is a 510(k) device (the best model) the specification developer holds the 510(k) clearance and is responsible for the DHF. In this case, the primary label names the Specification Developer and (in the fine print) includes the "Manufactured for...." language. As an aside, the Device Identifier (DI) encodes the Specification Developer, not the Contract Manufacturer, and, as a result, the Specification Developer creates the DI Record in the GUDID.

The second relationship is Distributor and Manufacturer. If a wholesale distributer does not manufacture, repackage, process, or relabel a device, then there is no labeling requirement. However if the distributor is a Repackager or Relabeler then the "Distributed by...." language may apply. In this case, the manufacturer puts the device on the market and holds the DHF, 510(k), etc. However, the DI may require some investigation.

If you put a convenience kit on the market, then it is a separate device. The implication is that the convenience kit must be classified and the appropriate pre-market path followed. This would require a DHF for the convenience kit, a separate DI, etc.

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Dan O'Leary
Swanzey NH
United States
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Dan: Comments appreciated, the "Specification Developer" was what made this one click for me.  I still have an unanswered question and will attempt to phrase it more succinctly this time around.

Regarding referenced convenience kit, we are looking to source part of the kit from an international supplier who must outsource one of the components in the kit, a sterile adhesive bandage.  Their current sub-contractor is not registered as a Foreign Exporter for this product. Questions:

1. If our supplier is registered as a Manufacturer, Contract Manufacturer and Foreign Exporter for convenience kits, can we import the convenience kit even though one of the components is sub-contracted from a supplier who is not registered as a Foreign Exporter for that component?

2. If that component is labeled with "Distributed By" along with our company contact info, what requirements must we meet for that specific item?  Do the requirements change if we request a private-labeled component with "Manufactured For" printed on the label instead?

I'm wondering if we're missing the forest for the trees by focusing too much on the 'specification developer' angle for this one item.  We are marketing a convenience kit and maintain design ownership for it.  The initial 'kit' will come from our international supplier with a few components already included.  We will add more components to it and market the finished product as our own.  The stumbling block keeps coming back to the adhesive bandage and our desire to have our company contact info on the component as "Distributed By".

-David

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David Burtard
Rio WI
United States
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I’m a little confused, so I’ll ask for some clarification. To adopt a somewhat simplistic view for FDA-CDRH, the world is divided into two parts: inside the US and outside the US. This view extends in two dimensions. One is the company location and the other is where the products are sold. In the classic 2 x 2 table, there are four kinds of companies. There is another, more complicated dimension that relates to the activity performed. You can see this classification in UCM053165.

You ask about a “Foreign Exporter”, which, for registration purposes is defined as a firm that “exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.” In our matrix, location is outside US, and sold is inside the US.

You say that you want to “source part of the kit from an international supplier”. I’m not sure what that means. Is it a US based company that sells outside the, a company based outside the US that sells inside the US or any of the other combinations?

In part of the question you say, “we are looking to source part of the kit from an international supplier”. In another part you ask about importing the kit. Are you importing the whole kit or just items that you include in the kit? I think the distinction is important because it hinges on the difference been a component and a finished device. Part of the issue is that US customs will care. If you are importing things regulated by FDA then the customs process is different, since FDA is involved at the port of entry.

I suggest that you draw an input map for all of things that go into you kit. It should list the kit items and go two or three levels deep as well as any significant services such as sterilization. This is a supply chain map. For each company in the supply chain, I would include the location, the product supplied, its classification (medical device, component, etc.), and the registration status with FDA.

In general, when you build a kit, the FDA regulates the kit as a device, but not necessarily the items in the kit. If one or more of the items is a device in its own right, then FDA will regulate it separately. If somebody is importing these items then their regulatory status must be clear. You need to contact the importer to be sure all is correct. If you are the importer, you need to have a conversation with your customs broker.