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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?
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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