FDA & Recall (voluntary) - Relabeling devices from a different distributor

R

regqual

#1
The scenario...we have a Class I FDA device. We are running low on inventory in EU and want to transfer from our USA distributor to the EU distributor. Although we are the HQ, we are strictly a design/devel site (product is manufactured globally.) The final packaging consists of the device itself, an accessory (which is expring soon), IFU.

The proposal...Bring product from USA distributor to our site, change the labeling for EU, replace the accessory with a current one, update the CEMarking labels.

Would this be considered a recall? Also, can we perform the activities listed at our site or would this be considered a "manufacturing" activity?

Many thanks for the guidance.
 
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G

gar4guv

#2
Re: FDA & Recall (voluntary)

I am sure this is not a recall. The definitions of a recall seems pretty clear:

21CFR7.3(g)Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

21CFR810.2(j)Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.


Also, I think the activity would not be a "manufacturing" one, but it would be considered a "repackaging/relabeling" one. This would require the site to be registered as a repackager/relabeler, as well as a specification developer.
 
R

regqual

#3
Re: FDA & Recall (voluntary)

Whew - yes, I didn't believe it was yet needed confirmation on my reading and understanding of the requirment.

As for: "Also, I think the activity would not be a "manufacturing" one, but it would be considered a "repackaging/relabeling" one. This would require the site to be registered as a repackager/relabeler, as well as a specification developer. "

We are not registered as any of those tags. This is the first time this scenario has presented itself. EU is buying up the product faster than USA and we just need to shift - with the changes listed - product across the pond. Without that registration, can we not go ahead?
 
R

Roland Cooke

#4
You wouldn't need to be registered as a relabeller or a spec developer for these particular activities, those are requirements of the FDA.

As these products are intended for the European market, you need to meet the requirements of the MDD; all stages of the manufacturing process (including relabelling/repackaging) need to be controlled under the responsibility of the legal manufacturer. If the product requires more than just relabelling for the European market (different electrical power requirements etc), then you will have a whole lot more work to do.

If the product requires EC certification, the Notified Body will need to be advised - in advance - of this significant change.
 
M

MIREGMGR

#5
As for: "Also, I think the activity would not be a "manufacturing" one, but it would be considered a "repackaging/relabeling" one. This would require the site to be registered as a repackager/relabeler, as well as a specification developer. "

We are not registered as any of those tags.
Hmmm. How are you FDA-registered?

***

Since you have product in EU, you must hold certificates for ISO 13485 and CE Mark...right?

***

As to the (I assume) re-purchase of the product from your US distributor(s): as long as the product is non-FDA-violative, that action will be a Removal under FDA rules, and not a reportable Recall. See http://www.fda.gov/cdrh/devadvice/51.html for precise definitions and comprehensive rules.

***

In my opinion, you cannot be an FDA Relabeler. A Relabeler is a distributor that buys product from a Manufacturer, then changes the label on that product to their own, with the effect that the original Manufacturer no longer is identifiable to end users. The Relabeler registration requirement is a special case of the usual distributor rules (i.e. distributors don't have to register), intended to assure that responsibility for adverse events reported to the FDA by end users is able to be attributed to a registered firm.

From the FDA's perspective, you're the Manufacturer of this product...that's the FDA regulatory position of a Specification Provider that markets the resulting product. The relabeling activity will be manufacturing activity from an FDA perspective.

***

You say that the product is "globally manufactured". Does the product that normally goes into the EU come from the same fabricator that makes product for the US? If not, do you apply equal regulatory oversight to the two contract suppliers?
 
J

Jimmy the Brit

#6
One question - is this a sterile device? If so, are you relabeling the primary package i.e. the sterile barrier system?

If you have, then this may well be a recall (an a potential Class 1 recall at that) unless you have validated the integrity of the sterile barrier in the presence of the "new" label. This is because some label adhesives break down the coating on these packaging materials allowing bacterial penetration and the loss of sterility assurance.

jimmy
 
G

gar4guv

#7
I guess I should have asked, but I was under the assumption that the facility was already registered as a specification developer since there is a US distributor for the product.

My rational for thinking the site need to be registered as a repackager/relabeler (I have a tendency to use them together) was due to the facility taking out the existing accessory from the package and replacing it with a new one.

I'm sure the specification developer registration is needed because there is a US distributor. The repackager registration, I think would cover the site, but I can see that being more open to interpretation.

However, registering as a manufacturer would certainly cover all those activities.
 
C

Chris Ford

#8
The scenario...we have a Class I FDA device. We are running low on inventory in EU and want to transfer from our USA distributor to the EU distributor. Although we are the HQ, we are strictly a design/devel site (product is manufactured globally.) The final packaging consists of the device itself, an accessory (which is expring soon), IFU.

The proposal...Bring product from USA distributor to our site, change the labeling for EU, replace the accessory with a current one, update the CEMarking labels.

Would this be considered a recall? Also, can we perform the activities listed at our site or would this be considered a "manufacturing" activity?

Many thanks for the guidance.

First, when you say, "our site", are you indicating that you are the EU distributor? You said that you're company designs the device, and it's manufactured elsewhere, then distributed.

This is definitely a manufacturing activity. The device isn't distributed yet. It's stored for distribution at the US distribution facility.

You've made a business decision to move inventory. There is no requirement other than the typical storage, handling, distribution requirements that would apply here.

You want to alter or refit devices that have already been manufactured, and it's unclear to me whether you want that activity performed at the EU distributor or at the design / development establishment.

In either case, treat this as a manufacturing process. Enter the inventory into the system as a "re-work work order" or whatever you call it at your company. If your company doesn't manufacture anything, you probably won't have such procedures. I would recommend documenting it either as a new process or enter it into your CAPA system, or have your manufacturer handle the rework. They should be equipped to handle rework work orders.

There are just a handful of Class I devices that might require a little more control than this. As stated by others, just be sure that your device meets the requirements of the MDD and CE mark.

I don't see this as a removal because the device has not been distributed. The inventory may have been sold to a distributor, but it's not distributed yet. In this case, you'd simply be buying your inventory back from the distributor.

Without knowing whether any special controls apply to your device, though it's not really possible to recommend a solid strategy.

Chris Ford
 
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