Odd Contract Medical Device Manufacturing Situation - Medical Device Packaging


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We are a device manufacturer, but we also have extensive contract manufacturing activity. One of our salespeople found a customer that markets a "Chinese finger trap" expanded-plastic-mesh device for rapidly applying surgical traction to a finger or thumb during trauma surgery. They've been selling this device nonsterile for users to autoclave before use. Now they want us to pouch, label and sterilize the device, using our validated capabilities.

From a technical perspective, this is straightforward. We can adapt the device into an existing packaging validation, and we can conduct a mini-validation to adapt the device into our master sterilization validation.

The problem is that it appears as if the customer may not be a registered medical device manufacturer, and may not be getting the devices themselves from a registered manufacturer...so there's no legal basis for its sale. I think perhaps they have concluded that the product isn't a medical device. Apparently they have concluded that there isn't a Product Code into which it fits very well, and therefore they don't need to be registered.

That isn't a viable conclusion, I don't think, given that their product is used in the sterile surgical field in contact with a patient, albeit always on intact skin. Also, it should be straightforward to classify the device as KQZ, so that argument is weak at best.

In any case, it puts us in an odd spot, being asked to apply an FDA-format medical device label onto a pouched, sterilized product that the marketer considers to be not a medical device, even though they sell it as one.

Can someone point me to a statement in FDA law or regs that specifically addresses the responsibility of a contract sterilization-and-packaging provider if/when the FDA determines that their customer is not appropriately registered?

I know of several past warning-letter instances that might be similar in context, but often warning letters are less than clear as to what rule the FDA considered to be applicable. What I need to support myself in a discussion with our management is a rule citation. I don't care which way it goes.

I know the rules pretty well, and I'm getting nowhere in exactly how to handle this. Any help out there?
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Juan Dude

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I did a quick search on the FDA site and found this, take a look at Section 10. Purchasing and Acceptance Activities from the Medical Device Quality Systems Manual, even though it's Small Entity Compliance Guide a read of the entire chapter offers some interesting concepts, like these:

Contract agreements between the manufacturer and contractors and/or consultants will vary in their degree of complexity. The most comprehensive is probably the agreement between the manufacturer and the contract sterilizer. Thus, the contract sterilization agreement is an excellent example of what is involved in setting up a contract between the device manufacturer and a contractor. The steps necessary for an agreement may be less extensive with other contracts than it is with the sterilization contract; however, the sterilization contract does provide a good basis for understanding this contractual agreement.


Manufacturers of medical devices frequently use contract sterilizers to provide sterilization processing for their devices prior to distribution. Contract sterilization of medical devices shall be performed so that the device manufacturer and the contract sterilizer meet the applicable parts of both the QS regulation and the labeling requirements of 21 CFR 801.
Hope it helps.

Wes Bucey

If it were my company, I'd simply require that the customer supply either FDA approval of the device or the equivalent of a "no action" letter from the FDA affirming the product does NOT require FDA registration.


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If it were my company, I might go in that direction as well, but it's not.

Market conditions and financial stresses being what they are, our top management isn't particularly eager right now to voluntarily self-regulate beyond what the stated rules require. They've asked me to prepare a rationale with regulatory citations, one way or the other.

I called DSMICA to get their input, but they didn't have anything definitive to offer. Their take is that there isn't a written rule, and they agreed that past enforcement practices as indicated by Warning Letters have been inconsistent. They asked that I put the inquiry in an email that could be elevated for discussion, and I did that earlier today. We'll see what comes back.


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i don't know how it is in Michigan, but in Texas a contract manufacture runs the risk of product detention. if a device isn't listed with the FDA and/or the spec developer isn't licensed with the state, the product (if its a finished one) would be considered misbranded. then the state could detain the product on-site, and if everything didn't get straightened out, they would require disposal of the product. this would be paid for by the facility that the product was located in. state officials here have the authority to do that.

this probably doesn't help you much since it applies only to TX, but you may find something in Michigan codes that could help you out.

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