I have a situation where a product could be classified as a system of (active) devices or a single active device, based on the way the component devices are packaged/incorporated/integrated together.

Does anybody know of a guidance document or some other source which gives clear guidlines about what can comprise a system (or procedure pack), in particular how the line is drawn between a system and a single device?

Cheers,

Steve.

Is the system/device for sale in the US?

Not yet. Classification is clear in the US. The question relates to GHTF based systems like Europe, Canada, and Australia.

Hi, I don't know of any specific guide to determining whether or not it is a system of active devices. However, I would not have any doubts as to what I would do. I would consider it a system, and produce my documentation based on that. If you're not sure, you can rest assured that a lot of people (auditors and other) don't know either, and then the discussion starts:bonk:

... and then the discussion starts:bonk:
Indeed. It was the length and voracity of the discussion I was hoping to minimise by referencing some guidance. :)

There are a few Cove participants who have a great deal of experience with medical devices, both US and abroad. Check back for more discussion.

I have a situation where a product could be classified as a system of (active) devices or a single active device, based on the way the component devices are packaged/incorporated/integrated together.

Does anybody know of a guidance document or some other source which gives clear guidlines about what can comprise a system (or procedure pack), in particular how the line is drawn between a system and a single device?

Cheers,

Steve.Steve, this is the only document I've seen. I don't know if it addresses your concerns. Let me know what you think.

When I thought I had a "system" (family) of products, I was told that they were single devices. Sort of a turn on your question but it might lend a good example. Recently, I submitted an application to Health Canada for a "family" of medical device testing kits. It has 2 variations of a kit in the family. 1 kit (complete kit) identifies 7 variations of a genetic type. The 2nd kit identifies only 1 of those variations within the "complete" kit. Hence, the 2nd kit is an "abbreviated" kit which identifies the one "most desired" variation of the 7 variations.

Health Canada requested 2 medical device applications, one for each kit. Although I didn't think that was correct, since we had several other cases like this in the past and they didn't require individual applications for those.

All in all, I wouldn't expect that EU, Canada, FDA requirements will be congruent. In this previous case, the FDA classification considered these 2 kits as one 510(k) submission.

The main line from my understanding is.......
If the intended use is the same, then the device is the same. What variation between "family" members is allowable? It seems that is up to the reviewer of the application. But, find solace in the fact that a call to the regulatory agencies is not a problem. They can help clear such issues up as well as point you to the applicable guidance documents that would help.

When I thought I had a "system" (family) of products, I was told that they were single devices. Sort of a turn on your question but it might lend a good example. Recently, I submitted an application to Health Canada for a "family" of medical device testing kits. It has 2 variations of a kit in the family. 1 kit (complete kit) identifies 7 variations of a genetic type. The 2nd kit identifies only 1 of those variations within the "complete" kit. Hence, the 2nd kit is an "abbreviated" kit which identifies the one "most desired" variation of the 7 variations.

Health Canada requested 2 medical device applications, one for each kit. Although I didn't think that was correct, since we had several other cases like this in the past and they didn't require individual applications for those.

All in all, I wouldn't expect that EU, Canada, FDA requirements will be congruent. In this previous case, the FDA classification considered these 2 kits as one 510(k) submission.

The main line from my understanding is.......
If the intended use is the same, then the device is the same. What variation between "family" members is allowable? It seems that is up to the reviewer of the application. But, find solace in the fact that a call to the regulatory agencies is not a problem. They can help clear such issues up as well as point you to the applicable guidance documents that would help.That seems contrary to the Health Canada website guidance:MEDICAL DEVICE GROUP FAMILY - A collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. (http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/apptype_typedem_main_principal_e.html)

Yes, I know. The statement received was:

"the "kits" do not have the same intended use. Therefore, we cannot list both of them on the same license." The intended use was very similar and still they did not consider them the same device.

I did challenge it and the outcome was to list them on 2 licenses.

That's why my previous comment was to ask the agencies what they will expect to avoid delay in getting the license accepted.

Yes, I know. The statement received was:

"the "kits" do not have the same intended use. Therefore, we cannot list both of them on the same license." The intended use was very similar and still they did not consider them the same device.

I did challenge it and the outcome was to list them on 2 licenses.

That's why my previous comment was to ask the agencies what they will expect to avoid delay in getting the license accepted.How long ago did you submit this to FDA?

Steve, this is the only document I've seen. I don't know if it addresses your concerns. Let me know what you think.
Thanks Al.

Its an interesting doc, but not quite what I was looking for. Looks like the issue I have is in the "rarely seen" tray. Time to get a good argument together just in case ...

It seems that is up to the reviewer of the application.
Indeed it does. :rolleyes:

Thanks all.
Steve.