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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?
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?