What technical documents need to be maintained for "manufactured for" items

K

KeithDMedi

#1
We currently sell a class I 510K exempt item which is registered and listed with the FDA and us as a distributor of said item are listed as repackager/relabeler. On the box our brand name is listed along with our part number, the manufacturer's CE and notified body and a manufactured by symbol with the manufacturer's name and address. What technical information is needed on site at our facility as the distributor if any? I can't seem to find anything on the FDA website, please help as I am new to regulatory and seem to be backing into a lot of documentation, thanks!
 
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M

MIREGMGR

#2
Whoever handled regulatory before you should have had this under control.

I gather from the content of your post and the forum you chose to put it in, that your company is located in USA. Thus your primary compliance issue is FDA, not EU.

If you're selling a product with the original label applied by the physical maker, in the packaging used by the physical maker, I don't see how you conform to FDA's definition of Repackager/Relabeler.

You could be a Specification Provider, if your business agreement with the physical maker defines them as a contract manufacturer of the product that you will market.

Or, you in fact could be a Distributor if your business agreement is defined to be 21CFR 801.1(c) compliant, i.e. they're the Private Label maker, you're the Private Label distributor. Note however that in this scenario, the labeling must include the required "Manufactured For" or "Distributed By" statement on the label, followed by the name and address of your company. This scenario is generally not consistent with using the same labeling for EU, because the terms used have conflicting meanings in EU and USA.

If you're Listed as Repackager/Relabeler, who is identified in your Listing as the responsible Manufacturer...the physical maker? So they're a Registered Establishment as well, and they've also Listed the product?

I don't see any other FDA status for your company that fits the description you've provided.

I appreciate that none of the above directly answers the question you asked, but your regulatory stance needs to be sorted out first.
 
K

KeithDMedi

#3
Yes both my company and manufacturer are both located in the US. Yes my concerns are with the FDA. I agree that we don't fit within what the FDA describes as a repack/relabel but that is what it was listed as and has never been a problem in the past. In any case repackager/relabeler or distributor do we need to keep a technical file or documentation on the product if it is there product that they private label for us? Thanks again.
 
M

MIREGMGR

#4
It appears to me that as you describe the situation, you are not a Repackager/Relabeler, even if you have Listed that way. There is no logic to determining what technical information to maintain to support such an FDA stance, because the most likely scenario in which FDA would review that information, an inspection, would first entail a review of whether your Listing was correct.

Similarly, you are not a Distributor selling a Private Labeled product, unless there is label content as explicitly required by 21CFR 801.1(c), that you have not described.

That leaves only the Specification Developer/Contract Manufacturer scenario. In this case, it would be your responsibility to maintain full product documentation, except in regard to documentation elements that you have contracted with another party to maintain, i.e. your Contract Manufacturer should be required by your business agreement to maintain the DHR.
 
K

KeithDMedi

#5
The label does in fact have manufactured for our company name and manufactured symbol and the manufacturers name in accordance with 21CFR801.1 c. My apologies that was not clear. I believe we are in fact a distributor selling a private label product, how do we list as so? Do we need to keep a technical file or any data as per the FDA?

Thank you!
 
M

MIREGMGR

#6
The label does in fact have manufactured for our company name and manufactured symbol and the manufacturers name in accordance with 21CFR801.1 c. My apologies that was not clear. I believe we are in fact a distributor selling a private label product, how do we list as so? Do we need to keep a technical file or any data as per the FDA?
If you qualify under 21CFR 801.1(c) as a Distributor, you are not eligible to be a Registered Establishment and therefore cannot List. The Manufacturer instead must be Registered and must List.

A Distributor per FDA need not maintain any product design/manufacturing files at all.

Note that FDA still generally does not recognize or accept the ISO "Manufactured By" symbol. FDA will read the label as if that symbol is not there, just as it will ignore the CE Mark.
 
K

KeithDMedi

#8
Thank you for that. In some cases we are a relabeler/repackager, and are listed as such. In these cases are we required to keep technical data on such product?
 
M

MIREGMGR

#9
A Repackager is a Manufacturer per 21CFR 820.3, and is responsible for 21CFR 820.80, 820.90, 820.130, 820.140, 820.150, 820.160, 820.180, 820.186 and 820.198, and possibly other sections. This will entail all the usual records.

In particular, a repackager is responsible for the new packaging adequately assuring that the device reaches the end user without impairment by the distribution process. Whether this assurance requires a little documentation or a lot will depend on the nature of the device.

My personal view would be that if the device may be impaired by a distribution or storage condition, the packaging should be validated for the appropriate distribution cycle and for storage conditions, and this of course would result in fairly extensive documentation of how you package and the results of the validation process.

A Relabeler also is a Manufacturer, and obviously is subject to 21CFR 820.120.

As a Relabeler, certainly you must have documentation of who is the physical maker; and I think it's implied that you must document how the device was labeled before you relabeled it, because the prior labeling is your only supporting evidence for any instructions for use, directions, precautions or other information on the label for which you are not the originator of that information.

In general, you are not required to keep "copies" of records for which the physical maker or another party that is upstream from you in the device creation process is regulatorily responsible, as long as you have adequate documentation of who that upstream party is and how they can be reached. You on the other hand are responsible for whatever information may be wanted/needed by FDA or another regulatory party regarding downstream activities, i.e. post market information, distribution records, complaints, etc.
 
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