Regulatory Open Forum

To answer the question, you need to clarify your relationship with the device manufacturer. There are multiple roles between the foreign manufacturer and a US company. They are not all, necessarily, performed by the same US company, but a US company could perform some, if not all, the rolls.

The roles that come to mind are US Agent, distributor, installation provider, and servicing provider.

Assuming you are only an installation provider and service provider, then, it appears you have no responsibilities to FDA. However, your customer, the foreign manufacturer, needs to bring you into their supplier management program as a service supplier. They are outsourcing part of their QMS requirements to you. Under their QMS requirements you should be providing installation data (820.170) and servicing data (820.200).

It would be best if your customer trained you on how to recognize a potentially reportable event under the Medical Device Reporting regulation.

Your customer may also require you to provide information to the US Agent, since the US agent forwards MDR complaints to the foreign manufacturer and maintains complaint files.

If you are the distributor or the US Agent, there are other requirements, which I did not raise.

All:

Thank you all for your feedback.  To clarify, we are registered as the initial importer with FDA for our parent OUS company (the registered manufacturer) and we handle all North American distribution of our products.  But we also perform field support such as device installation and device servicing.  We are not ISO registered/certified.  When I reviewed the part 807 and the FDA resources I did not see anything that specifically made reference to registration requirements for install/service activities so I was requesting feedback on how this has been approached in the industry.

Based on your responses I conclude that there are no additional registration requirements for the installation / servicing activities of our organization.  Of course we comply with the relevant QSR/ GMP requirements.  My concern was that performing installation and servicing might have required us to also be registered as part of the manufacturing organization but you have assuaged my concerns.

Thank you all for the input in helping arrive at a conclusion.

Kind Regards,

Brian

I must say, I have always thought FDA failed the consistency test with its registration definitions. 

Both installation and servicing are included in the QSR, and were included back when it was still just the GMP regulation (right?).  To me this means that these activities are part of the manufacturing process, so it makes no sense to me that facilities which carry out these two manufacturing "steps," are excluded from registration.  (This is not to say that I think they should be required to register, just that it makes no sense to me that they are excluded from registration by not being considered contract manufacturers.  I would be happier if they were acknowledged to be contract manufacturers and then were excepted from the requirement.)

I'm also bothered by the fact that a contract sterilizer is defined separately from a contract manufacturer. The latter is defined as a facility that "manufactures a finished device to another establishment's specifications."  I don't think it's finished until it's ready for use, and if it will be sold sterile, it isn't ready to be used until it's been sterilized.

That said, manufacturing is not my strong suit.  Perhaps others here can shed some light on how this all hangs together better than I think it does?  I do think that registration requirements should be consistent with the QSR, when you consider that whether or not a facility will be subject to inspection for QSR compliance is essentially determined by whether or not it is registered.

David, my bad.  I forget that there are two definitions of "bother," one action based and one emotion based. 

The definitions FDA has presented to support its registration requirements do not "worry, disturb, or upset" me.  They caught my attention because, first, I'm writer/editor at base, so written inconsistencies always catch my attention, and, second, because, as both a regulatory professional and writer/editor, I've always found FDA's device regulations to be delightfully well organized, clear, and consistent, especially having started with their pharma regulations, which I find to be rather otherwise.  (Although, if you enjoy (is that an emotion?) the intellectual challenge of navigating redundant, confusing, makes-no-sense regulations, I would highly recommend the MDDs and MEDDEVs over anything FDA has ever written.)

Once these inconsistencies caught my attention, I could have simply noted them and gone on (which I typically must do, the world being awash in inconsistencies), but in this case, I "took the trouble to do something," which was to consider why I found them inconsistent and, more to the point, whether they might not be inconsistent, and that I might simply be missing something that resolved the apparent inconsistencies.  This struck me as a viable hypothesis because 1) I normally find FDA's device regulations to be strikingly consistent, and 2) manufacturing is not my strong suit.  This was the point of my post...I was hoping someone who was more knowledgeable in this area might shed some light, and perhaps I would gain a better understanding of these definitions, and even perhaps of the conceptualization of the manufacturing process.

So, now that I am back to my point...whew!...I am pleased to learn that someone has taken my points and bothered to consider them, and I appreciate your comment on the subject of contract sterilizers, but I'm still not clear why sterilization would not be considered part of the manufacturing process, arguably speaking or otherwise.

Great discussion. As David and Dan suggested, the manufacturer FDA QSR should include the data on installation and servicing.

The service component is also related to the complaints aspect which would be the US Agent / Importer responsibility. Also another point worth considering for you Brian is whether you conduct any testing on the equipment prior to shipping it to the customers as this has to be performed in accordance with the manufacturer's instructions and procedures.

Julie,

You said, “I'm also bothered by the fact that a contract sterilizer is defined separately from a contract manufacturer. The latter is defined as a facility that "manufactures a finished device to another establishment's specifications”. I don't think it's finished until it's ready for use, and if it will be sold sterile, it isn't ready to be used until it's been sterilized.”

While that is the colloquial view, it is not the technical definition. In 21 CFR §820.3(l) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

In the preamble #25, FDA says, “Since the 1978 CGMP regulation was promulgated, FDA has been repeatedly asked whether devices intended to be sold as sterile are considered subject to the CGMP requirements, even though they have not yet been sterilized. The agency had intended the new definition to make explicit the application of the regulation to the manufacture of sterile devices that have yet to be sterilized. Although FDA believes it should be obvious that such devices are subject to CGMP requirements, some manufacturers have taken the position that the regulation does not apply because the device is not ‘finished’ or ‘suitable for use’ until it has been sterilized.

“To better clarify its intent, FDA has amended the definition to add that all devices that are capable of functioning, including those devices that could be used even though they are not yet in their final form, are ‘finished devices’. For example, devices that have been manufactured or assembled, and need only to be sterilized, polished, inspected and tested, or packaged or labeled by a purchaser/manufacturer are clearly not components, but are now in a condition in which they could be used, therefore meeting the definition of ‘finished device’.”

21 CFR §820.3(o) says, “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, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.”

The requirements for registration are in Part 807, not Part 820. It does seem a disconnect that “installation” is not included in Part 807. However, installation should not change the device characteristics, whereas the other tasks, expect perhaps initial distributors, do alter the device.

Dan, thanks for the additional information.  Now I have another question:

 “Since the 1978 CGMP regulation was promulgated, FDA has been repeatedly asked whether devices intended to be sold as sterile are considered subject to the CGMP requirements, even though they have not yet been sterilized."

Why would anyone ask this question?  And why would it matter?  If the devices are intended to be sold as sterile, but are not sterile, then they can't be sold, right?  So who cares if they have been manufactured according to CGMP or not?  On the other hand, if at that point the manufacturer wanted to sterilize them and sell them, then they would be subject CGMP, but it would be too late to manufacturer them according to CGMP, wouldn't it?

Is this perhaps a question asked by contract manufacturers, who manufacture a device and then hand it off to the legal manufacturer for sterilization?

Julie,

My understanding of the issue is FDA’s blocking the argument you just made. They were concerned that companies would argue that since the product is not a device until all operations are complete and it is in stock, ready to ship. Consequently the product is not a device, more like a component, and there cannot be regulated by FDA.

The same situation applies to contract manufacturers, but you need to be careful here because of the two, different, means of contract manufacturer. In this case a contract manufacturer makes a finished device for a specification developer. That contract manufacturer is a manufacturer, even if the device is not ready to ship to the final company. FDA, I believe, would argue that it doesn’t make any difference whose production facility employed, FDA still regulates.