FDA definitions - Repackager vs. Domestic Distributor

[kellascat]

At my company there is some disagreement about rather or not to list our distribution warehouse as a repackager with the FDA.

FDA definition fo a Repackager: Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

This what we want to do at our warehouse:

1) Vendor sends a shipping case with 50 qty of a Class II device to our warehouse.

2) Warehouse breaks down the bulk shipping case, and then packs 10 qty in a shipping case for shipment to the customer.
Shipping case has our company label with our internal PN and Lot #, and a description of the contents.

3) Warehouse does not change the device packaging or its use instructions.


Question: Is the warehouse "distributing" or "repackaging"?

 

[maaquilino]

Check the preamble to 820; do a search on 'repack' and the info in the preamble may clarify this a bit more.
http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm

 

[Ajit Basrur]

At my company there is some disagreement about rather or not to list our distribution warehouse as a repackager with the FDA.

FDA definition fo a Repackager: Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

This what we want to do at our warehouse:

1) Vendor sends a shipping case with 50 qty of a Class II device to our warehouse.

2) Warehouse breaks down the bulk shipping case, and then packs 10 qty in a shipping case for shipment to the customer.
Shipping case has our company label with our internal PN and Lot #, and a description of the contents.

3) Warehouse does not change the device packaging or its use instructions.


Question: Is the warehouse "distributing" or "repackaging"?

A Distributor is defined per 21 CFR Part 821.3 as - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=821.3

(h) Distributor means any person who furthers the distribution of a device from the original place of manufacture to the person who makes delivery or sale to the ultimate user, i.e., the final or multiple distributor, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

Likewise, Distribution is defined as -

j) Distributes means any distribution of a tracked device, including the charitable distribution of a tracked device.

In the wake of the above defintions, would you consider your activities under "Repackagae" or "Distribute" ?

 

[MIREGMGR]

Based on the provided information, if you do not change the device immediate-package labeling, it sounds to me as if you're a distributor.

 

[kellascat]

I think distributor is correct.

However, someone at my company insists the warehouse should be listed as a repackager/relabeler with the FDA even though the warehouse only places vendor supplied items in a shipping carton for shipment to customer.

 

[MIREGMGR]

Call up FDA DICE (used to be DSMICA) and ask them. Take notes of the conversation. That's your definitive answer. If the "someone at your company" is the doubting type, have them listen into the DICE conversation. (But listen only...DICE won't participate in a conference-call discussion or explain basics to a non-regulatory person, and you only get five minutes.)