Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I'm trying to understand why FDA wants repackagers to be registered. The definition of a repackager being one who "packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers)."

I understand at a theoretical level that they need to be able to trace a product through the supply chain and identify all the key players/brand names. However, I would be curious to know how others apply the requirement. Is there a general guideline to follow? 

The reason for my question is that we have a multi-pack of a product. Each individual piece is labeled in a way that makes it, what I consider, a Finished Medical Device. Marketing now wants to breakdown the multi-pack down to the individual device and distribute the individual device as a sales tool/sample handout (consumer product). The individual packet has all the relevant labeling but the packaging would be done by a third-party. In my opinion, it seems reasonable to consider all packaging outside the individually labeled device as a shipping container but I can see how that is a liberal interpretation of both the definition and the situation. Does anyone have similar experiences or suggestions on how FDA may see this situation? Would you suggest that the third-party register with the FDA as a repackager? 

I'm having a hard time seeing the risks that FDA might identify in having a third-party reconfigure the packaging for a low-risk device from a 25-count to single-count.

Thanks for any feedback.

The QSR preamble gives some discussion of why repackaging is included:  https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

​Packaging and labeling can both significantly affect the safety of a medical device.

If you took some other manufacturer's devices and changed their packages and/or labels, that would give you a manufacturer's responsibilities for ensuring safety.

If you're modifying the packaging and/or labeling of your own devices (or hiring someone to do it for you), then you remain the legal manufacturer, and you're responsible for ensuring that the activities are carried out appropriately.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 04-Oct-2019 00:01
From: Anonymous Member
Subject: Intention behind registering repackagers with FDA

This message was posted by a user wishing to remain anonymous

Hello,

I'm trying to understand why FDA wants repackagers to be registered. The definition of a repackager being one who "packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers)."

I understand at a theoretical level that they need to be able to trace a product through the supply chain and identify all the key players/brand names. However, I would be curious to know how others apply the requirement. Is there a general guideline to follow?

The reason for my question is that we have a multi-pack of a product. Each individual piece is labeled in a way that makes it, what I consider, a Finished Medical Device. Marketing now wants to breakdown the multi-pack down to the individual device and distribute the individual device as a sales tool/sample handout (consumer product). The individual packet has all the relevant labeling but the packaging would be done by a third-party. In my opinion, it seems reasonable to consider all packaging outside the individually labeled device as a shipping container but I can see how that is a liberal interpretation of both the definition and the situation. Does anyone have similar experiences or suggestions on how FDA may see this situation? Would you suggest that the third-party register with the FDA as a repackager?

I'm having a hard time seeing the risks that FDA might identify in having a third-party reconfigure the packaging for a low-risk device from a 25-count to single-count.

Thanks for any feedback.