Hello,
Yes, sorry about that made the correction - had not looked at specific regulation in a bit. If your company is still making the product (Contract Manufacturer) and if your customer is now considered the legal Manufacturer, then it does not make too much difference. The legal Manufacturer is still considered whosever name is actually on the product. So as an example, if the labelling says "Manufactured For Company B" and the product is made by Company A, the FDA would still view Company B as the legal manufacturer. This also has to do with how Company A and Company B are registered in the FURLS system and what contract/agreements are in place between the companies. So even before you made this change, if the labelling said "Distributed By Company B" and Company A's information was no where on the device labelling, then Company B would still be considered the legal manufacturer. That is fundamentals, does not mean this is how always managed - so the important thing again is how the entities are registered in the FURLS system.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Oct-2021 08:20
From: Anonymous Member
Subject: Label Misbranding If Entity Changes Responsibility?
This message was posted by a user wishing to remain anonymous
Hi Richard
Section 801.1(c) does state "distributed by" as an option. So if the bags continue to state "distributed by" after the sale this would not be considered misbranding even though that entity is now the legal manufacturer (FURLS is updated and so forth)?
Original Message:
Sent: 20-Oct-2021 02:56
From: Richard Vincins
Subject: Label Misbranding If Entity Changes Responsibility?
Hello Anon,
Might be a bit of semantics because even if the same company is distributing a product and also considered the manufacturer, could assume this would be the same. For medical devices according to 21 CFR 801 there are actually only two phrases which can be used: 'Manufactured By' and 'Manufactured For' - there is no such terminology in the regulation for Distributed By. From my view, the Manufactured By should be on the product labelling with your company name and when the purchase of the 510(k) is made, then the Manufactured By would then be your customer. Though, if your company is still making the product then it should actually still be Manufactured For and in essence your company would be a Contract Manufacturer, where your current customer would then be considered the (legal) Manufacturer. More importantly is updated need to be made in the FURLS database about who is the Manufacturer of the device and who is responsible for the device listings. Then internally document what has happened with the transfer of the product from one entity to the other. Create a Quality Plan which discussed how these bag bodies inventory would be used up and how any changes to labelling would be reflected.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 18-Oct-2021 17:44
From: Anonymous Member
Subject: Label Misbranding If Entity Changes Responsibility?
This message was posted by a user wishing to remain anonymous
A customer of ours has been the distributor of a product and their correct name and address appears on the device with the notation "Distributed By." The customer is now proceeding to purchase the 510K from the owner. There is a large inventory of bag bodies in stock which are pre-printed with the "Distributed By" and the customer's name and address. The customer is requesting to use up the bag body inventory. Would the FDA consider this mis-branding as the "Distributed By" should be replaced with "Manufactured By" since they are now the legal manufacturer?