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Distributor and 21 CFR Part 820.50 Purchasing Controls

M

MJW66

#1
My company distributes a class I medical device in the USA that we receive from the Initial Importer. It does carry our name such as, "Manufactured for Company XYZ" to show the exact nature of this relationship. We've had issues with the Initial Importer and further upstream, the non-compliance gaps to various parts of the QSR with respect to the manufacturer. We have been trying to resolve these issues with the manufacturer, albeit somewhat unsuccessfully. Although I know that these need to be resolved, I have always argued that strictly from a regulatory responsibility, we are exempt from 21CFR820.50 Purchasing Controls. My basis is that since we are a distributor of this device, we are not part of the definition, manufacturer, as articulated in 21CFR820. However, my company is also a registered manufacturer of medical devices where these regulations obviously do apply. Can I rightfully take the stance that we are exempt from Purchasing Controls with respect only to this private branded distributed device?
 
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Ronen E

Problem Solver
Staff member
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#3
My company distributes a class I medical device in the USA that we receive from the Initial Importer. It does carry our name such as, "Manufactured for Company XYZ" to show the exact nature of this relationship. We've had issues with the Initial Importer and further upstream, the non-compliance gaps to various parts of the QSR with respect to the manufacturer. We have been trying to resolve these issues with the manufacturer, albeit somewhat unsuccessfully. Although I know that these need to be resolved, I have always argued that strictly from a regulatory responsibility, we are exempt from 21CFR820.50 Purchasing Controls. My basis is that since we are a distributor of this device, we are not part of the definition, manufacturer, as articulated in 21CFR820. However, my company is also a registered manufacturer of medical devices where these regulations obviously do apply. Can I rightfully take the stance that we are exempt from Purchasing Controls with respect only to this private branded distributed device?
I estimate that unless the manufacturing operations and the private label distribution operations are very clearly separate (e.g. 2 distinct geographic locations or the like), it's going to be difficult to argue differential application of regulations, on a product-line basis. It may be legal but complicated nonetheless.

Please also note that specification developers (who do not manufacture) are not automatically entirely exempt from part 820. Who is the specification developer / owner?
 
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G

Gert Sorensen

#4
My company distributes a class I medical device in the USA that we receive from the Initial Importer. It does carry our name such as, "Manufactured for Company XYZ" to show the exact nature of this relationship. We've had issues with the Initial Importer and further upstream, the non-compliance gaps to various parts of the QSR with respect to the manufacturer. We have been trying to resolve these issues with the manufacturer, albeit somewhat unsuccessfully. Although I know that these need to be resolved, I have always argued that strictly from a regulatory responsibility, we are exempt from 21CFR820.50 Purchasing Controls. My basis is that since we are a distributor of this device, we are not part of the definition, manufacturer, as articulated in 21CFR820. However, my company is also a registered manufacturer of medical devices where these regulations obviously do apply. Can I rightfully take the stance that we are exempt from Purchasing Controls with respect only to this private branded distributed device?
As far as I know, what it comes down to is the manufacturer of the device in accordance with the definition of the FDA.

21 CFR 820.3, (o):
Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabelling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

So, for this specific device:
If you fit the above then 21 CFR 820 is relevant for all aspects of your operation.
If you do not fit any of the above, then you do not need to have comply with 820 for this product.

The entire responsibility lies with the manufacturer.

However, as a distributor you are required to have MDR procedures in place for the device as described in 21 CFR 803, and your device registration has to indicate that you are also a distributor, under 21 CFR 807.25(b), the owner or operator of an establishment, in its registration, "shall identify the device activities of the establishment such as manufacturing, repackaging, or distributing devices.
 
M

MIREGMGR

#5
Two or three Warning Letters have been issued over the past few years in circumstances similar to yours, where a distributor of a problematic medical device is also a Registered Establishment and manufacturer of other medical devices of their own.

The gist of those Warning Letters, as I understood them, was "theoretically you aren't subject to this rule, but because you're a Registered Establishment we're going to ding you anyway because your approach wasn't consistent with the spirit of the rules and you either knew that, or should have".
 
M

MJW66

#6
Two or three Warning Letters have been issued over the past few years in circumstances similar to yours, where a distributor of a problematic medical device is also a Registered Establishment and manufacturer of other medical devices of their own.

The gist of those Warning Letters, as I understood them, was "theoretically you aren't subject to this rule, but because you're a Registered Establishment we're going to ding you anyway because your approach wasn't consistent with the spirit of the rules and you either knew that, or should have".

That is an interesting thought and I could see where the FDA may take "liberty" to extend purchasing controls over a distributed product, which would obviously not be listed as a device in the company's FDA registered listing. With that being said, it is the "spirit of the rule" that makes it troublesome for me. If they meant to include distributors in the spirit of the rule, then they should have listed distributors as responsible for 820.50.

I didn't realize it until last night, but I asked this question 2 years ago: http://elsmar.com/Forums/showthread.php?t=41569

Post #5. You responded in post #6.

Thanks for everyone's input, it is appreciated.
 
K

Katalina

#7
Do you happen to recall the specifics of any of the warning letters so that I might look them up?
 
M

MIREGMGR

#8
No. I review all medical device Warning Letters in the weekly report, but I only index the ones that I regard as relevant to my employer's operations, and we do relatively little distribution and in any case are unlikely to be gigged for those operations because we apply our full QMS to them.
 
G

Gert Sorensen

#9
Do you happen to recall the specifics of any of the warning letters so that I might look them up?
Try searching the fda website's warning letter section for paragraph 820.50 and refine the search for distributor or distribution. That should get you close to what you are looking for.
 
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