FDA Medical Device Accessory Packaging Requirements

Q

qcqueen94

Hi everyone - My company is currently not FDA registered as the vast majority of our products are components sold directly to finished device manufacturers. However, a recent prospective customer has asked us to quote some carrying equipment for one of the medical devices it makes. The print for the equipment says, "This item is a finished device accesory".

The FDA website says you do need to register if you make "accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user". Thes parts would just be polybagged with a simple stick-on part # label and bulk packed. Before shipping their devices to its end users, our customer would have to unbox the unit, remove the polybag to insert the device into the carrying equipment, and then repackage it.

So I'm a little confused on whether we would have to register with the FDA for this type of item. I appreciate any help you can provide. Thank you! :D
 
M

MIREGMGR

Will the "carrying equipment" you make be used by an end user, or just be (in effect) packaging to get your customer's product to the end user after which it will be discarded or set aside?

In the latter case, it's a component. In the former case, it's an accessory.

If your product is an accessory, it probably is appropriate for that product to be labeled on the product itself, not on the polybag, so that the labeling survives the re-packing process conducted by your customer. Then the end user will receive that labeling, which will identify the accessory and any relevant instructions for use and warnings/ contraindications.
 

Ronen E

Problem Solver
Moderator
Hi,

Indeed it's a grey area.

If this "carrying equipment" (what makes it different from just "packaging"?) is also distributed to the end user stand-alone (i.e. without the other device inside), say, as an option to another form of carrying which the end user already has, then it may well be considered an accessory. If it's only supplied with the device, and is part of the default configuration, it's probably just a component.

Further, if your customer deems it an Accessory (in the regulatory sense) and thus subject to the entire applicable regulation - just like a medical device, they would have to accept that you label each unit in a compliant manner, and they are not to remove the label (otherwise they'd become relabelers of this accessory). Such label would bear your details as the manufacturer, unless you come to an agreement with them that they take on the regulatory responsibility - in this case it would need to show their details.

Cheers,
Ronen.
 

robert.beck

Involved In Discussions
This is a related topic, not quite the same question as the original one but it fits under this topic:

We have a package that contains five accessory items in it. these items are single use, class I, 510(k) exempt devices that are accessory to a class II 510(k) cleared device. The five items are not easily traceable at this time because they may each be from a different lot. The package does have an identifier, and each of the five items inside it has a lot identifier. There is no linking or tracking between the lots in a package and the package itself.

What is the FDA regulatory basis for accepting or rejecting this state of affairs?
Also, same question for the MDD. It looks like the MDD does not accept but I found conflicting statements, for instance (from Annex VI, Part C):

3.1 A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.

4.3 For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.

5.6 The database shall allow for the linking of all the packaging levels of the device.

my conclusions so far are:
1. I don't know what FDA says about this.
2. sections 3.1 and 5.6 imply the current situation is not acceptable.
3. section 4.3 states that each of the individual items must have its own UDI, but implies that the package does not need any label, so linkage is not relevant.

Your comments welcome ...
 
Last edited by a moderator:

QAengineer13

Quite Involved in Discussions
Its an interesting point, the FDA Guidance on this is; on your section 4.3 is :

"A.6. Question: Are single-use devices required to bear a UDI?
Generally, a single-use device is required to bear a UDI on its label. One general exception to that requirement is where individual single-use devices all of a single version or model are distributed together in a single device package and intended to be stored in that device package until removed for use. Then the UDI is not required on the device label, but is still required on the device package. This exception is not available for any implantable device.Also, if the devices are intended for individual commercial distribution, the device label and package for these individual devices is required to bear a UDI. 21 CFR 801.30(a)(3) Single use devices are not required to bear a permanent UDI, even if re-processed. 21 CFR 801.45(d)(3)".
 

duduky23

Registered
QAengineer13 ,

To your point, If I have a medical device class I, non-sterile, that comes packed in a poly-bag (10 units per dispenser box)- does each unite need to carry the lot and expiry or only the dispenser box? The device is not meant to be distributed as a single unit.

Thanks,
David
 

robert.beck

Involved In Discussions
Your last sentence is not clear. how are these units used once removed from the package? are they used once, meaning they are single-use? or are they used in conjunction with another device?

I have not been able to find a guidance with the exact statement left by QAengineer13. However, Unique Device Identification: Direct Marking of Devices (11/17/2017) states:

“For devices required to bear a UDI on their device label, the UDI regulation at 21 CFR 801.45 requires a UDI direct marking on a device if the device is intended to be used more than once and intended to be reprocessed before each use. “

my conclusion is that direct marking is intended to be used in situations where the device is used and re-used, and the marking may become separated from the original label and package.
 

QAengineer13

Quite Involved in Discussions
Its an interesting point, the FDA Guidance on this is; on your section 4.3 is :

"A.6. Question: Are single-use devices required to bear a UDI?
Generally, a single-use device is required to bear a UDI on its label. One general exception to that requirement is where individual single-use devices all of a single version or model are distributed together in a single device package and intended to be stored in that device package until removed for use. Then the UDI is not required on the device label, but is still required on the device package. This exception is not available for any implantable device.Also, if the devices are intended for individual commercial distribution, the device label and package for these individual devices is required to bear a UDI. 21 CFR 801.30(a)(3) Single use devices are not required to bear a permanent UDI, even if re-processed. 21 CFR 801.45(d)(3)".

The Excerpt above is from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf
 

QAengineer13

Quite Involved in Discussions
Here you go Robet.Beck the guidance is from here https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM410439.pdf

Regarding the Direct Marking, I would recommend you applying this guidance principle:
• [url]https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM452262.pdf 2[/URL]

Section C1 and C2 related to Reprocessing, your comment about

" used in situations where the device is used and re-used, and the marking may become separated from the original label and package". so your conclusion is not what the FDA's current thinking is!
 
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