Does this situation present problems?

We make a broad family of Class II KKX and MMP sterile equipment covers, with fairly large product numbers. Some products are marketed under our name, and others are made to fit OEM equipment and are marketed by them. In the latter cases we probably are a Contract Manufacturer per FDA rules, though that status is muddied in some cases when the OEM expects us to have full unsupervised control of product design, product validation and process validation. We got our first 510(k) for products in this family in 1978, so our track record is pretty long. These products are normally single-pouch-packaged and EtO sterilized.

We are currently selling some of these products in bulk-packed non-sterile form to several kit packer customers. In some cases we can verify that fact from establishment registrations, but in other cases the kit packing activity and subsequent sterilization is captive within a hospital buying group, thus there is no further sale and no separate business to register.

It may be that some of these kit packers are selling their kits as Class I. Our 510(k)s for the products we provide are not applicable because we deliver in bulk non-sterile form, not consistent with the 510(k) product conditions. We don't have any reliable information as to our kit-packer customers' conditions of sale, regulatory compliance or sterilization validation.

Since our delivery is bulk, our products are not individually labeled. Generally we don't know what labeling is applied when they're in kit form, other than that the customer labels the kit without using our name.

Our understanding is that, like a Re-Labeler, a Re-Packager (FDA term for kit-packer) has full medical device regulatory responsibility, thus need not buy from a medical device Manufacturer. Of course, it happens that we are a Manufacturer, but the past assumption has been that we have no regulatory responsibility past our bulk delivery to these customers.

Anyone have any thoughts on this set of circumstances?

Any takers ?

Wow ! this is very very complicated item:

Essentially your company acts in the following manner:

1. Manufacturer: You have 510K for class II medical device that you sell under your own brand name.

2. Contract Manufacturer: Here you do have all the responsibilities of item #1. I dont believe that you have to worry at all. However, you have to have a clearly defined relationship with your client. This client is responsible for compliance with relevant sections of 21CFR820; which are distribution related, customer complaints, internal audits, supplier evaluation and audits etc. etc.

3. Component manufacturer: In the cases where you sell bulk non-sterile products to manufacturers who then sterilize them and use them; they are required to be in full compliance with 21CFR820 and maintain a relationship with you which is well defined (contractually). They are responsible for ensuring that you comply with their specifications ; which should be no problem for you as you have a 510K for the product and are presumably compliant with QSR.
Where you sell "components" to kit packers for internal use; you have no obligations at all. These customers only consume the product for internal use and have extemporanous preparation procedures; however, they do not market the product and dont place it in interstate commerce.

obviously there is lot more detail on each process that is needed; but this is the first cut from your message.

The essential question I'm trying to ask, from a Management Review information-provision-responsibility perspective, is the extent to which we inherit additional quasi-legal compliance responsibilities when:

1. Our relationship with a particular OEM, Re-Labeler or Re-Packager customer doesn't cleanly fit into any of the FDA's grossly-oversimplified relationship categories; and

2. We are informally aware that our customer is not fully performing their end of the total regulatory picture.

I suppose it's really a legal question. Does anyone know of a regulatory-law forum? :cool:

I know a couple of good firms in DC. My first choice would be Olson, Frank & Weeda. Ask for Stephen Turman - he's X-FDA General Council.

I think you are an unfinished medical device (like component) manufacturer, and you have no regulation responsibility. In 21CFR820, FDA encourage but not enforce that the unfinished medical device manufacture having the quality system comply with the QSR.

Hope this information can help you

I agree in this case you would be the contract manufacturer and are not required to comply with FDA regulations. However, it would be good to send a written correspondence to the customer or have a contractual agreement that they are responsible for fulifilling their FDA obligations.

Thank you, LeeFu and rakma. However, my concern is not our compliance in regard to manufacturing operations, where the fact that in this instance the FDA would regard us as a Contract Manufacturer would be irrelevant since we make these products in a Manufacturer context.

Rather, our concern is what our legal responsibility may be if our customer is not complying with their legal responsibilities.

Regarding "...send a written correspondence to the customer or have a contractual agreement that they are responsible for fulifilling their FDA obligations", I want to manage our legal responsibilities without causing the Sales Department to put a contract out on me, if I can. :D

As a side note, a patient/user risk analysis isn't relevant here, because we don't have any reason to think any of our customers are not properly sterilizing their kits, and our products have full quality irrespective of how the customer sells them. The problem is only that if a kit containing a Class II device is sold as a Class I, FDA regulatory oversight doesn't happen.

hello Miregmg,

I suppose that I get the point.

If your customer perfome any activity on your product, like modification of the label or sterilization, then your act is the unfinished device manufacturer without regulation responsibility.

In the other case, if they perfome no activity on your product, keep your original label, and put your device in their kit, then you are the manufactuer with the regulation responsibility, and they might be considered as only a distributor of your product. In this case, they can sell your product in their Class I kit, cause your product has 510(k) number. So my recomendation is you shall sell them your sterilized product to comply with the 510(k) Submission.

Hope this information can help you.

We probably don't need to pursue the OP question further, since it's had plenty of exposure, but I feel obligated to straighten out a couple of final misunderstandings for the benefit of those who might be reading.

If your customer perfome any activity on your product, like modification of the label or sterilization, then your act is the unfinished device manufacturer without regulation responsibility.

In the other case, if they perfome no activity on your product, keep your original label, and put your device in their kit, then you are the manufactuer with the regulation responsibility, and they might be considered as only a distributor of your product.

No, this is a misapprehension.

1. Kits of the sort in question normally involve kit packaging that precludes inclusion of components that are already individually packed in the sort of soft pouch or form-fill-seal packaging that is required for the EtO sterilization that is most common (and that we use) for sterile disposable equipment covers. That's one reason why the kit packer buys from us in bulk non-sterile form rather than in individually sterile-barrier-packaged sterile form.

2. Kits of this sort normally are prepared in cleanroom but non-sterile conditions, and in every case of which I'm aware, the multiple components are almost always all non-sterile at time of kit packing. It's almost always technically undesirable from a materials perspective, and possibly raises ISO10993-7 questions, to EtO sterilize tortuous-path-folded equipment covers more than once. Thus the kit packer needs to buy non-sterile components so that they can sterilize without creating additional problems for themselves.

3. Kit packers almost always are concerned with component cost, and sterile, barrier-packed components are significantly more expensive than bulk non-sterile components of the same type.

4. "Bulk" components inherently are not individually labeled, therefore are not consistent with the conditions of a 510(k) for their marketing in sterile, individually barrier-packed, individually labeled form.

Under normal conditions, it would be neither packaging-practical, nor product-sterilization-desirable, nor cost-effective for a kit packer to follow an operational path that would be consistent with them defining themselves as a Distributor per FDA definition.

In this case, they can sell your product in their Class I kit, cause your product has 510(k) number.

As mentioned in the OP and explained above, our 510(k) clearance does not apply to the bulk non-sterile version of our Class II equipment covers. And, I believe you are fundamentally incorrect in stating that it would be regulatory-legal-acceptable to sell a kit containing a legally marketable Class II device as a Class I. We are reasonably sure that such a kit should be FDA-Listed as Class II, and marketed as Class II.

Thank you for the input, though. Discussions of such issues always have the potential to help solve problems.

MIREGMGR,

I understand and agree with all your clarification and I don't want to pursue this too much, but to conclude: bottom line is if you are selling the device in bulk non-sterile form, then you do not have the legal responsibility of regulatory compliance for the final product (kit). It would not affect you if the repackager markets it as class I or class II. It would not be labeled under your name anyways.

We had seen a similar issue and our take on this was as I mentioned above, though the repackager were not selling the device as class I, we were not sure about their sterilization revalidation of the kit. The sterilization validation of the kit would need to be redone though the method was still ETO. We did send a letter to them indicating that they should follow their own regulatory procedures for assessing the regulatory implication of repackaging. I do understand your point on wanting to avoid any agreement issues.

Anyways, it was a good discussion. Thank you. Good luck for resolving the issue.

Rakma

Oh...I really feel sorry for my wrong word, and thanks for your opioion

:thanx: