A US company has a 510(k), establishment registration as a manufacturer and specification developer, and a device listing for an 868.5260 breathing circuit bacterial filter. If this company wishes to outsource molding and assembly of this accessory device to a plastic molder in the US, is it necessary for the plastic molder to register and list? The plastic molder will provide the filter to the original company unlabeled, unpackaged, in bulk. The plastic molder does not sell or distribute to anyone other than the original company. The reason for my confusion is the wording of 807.20 (a) (6) which says "Manufactures components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose...." If the product is not packaged and labeled for commercial distribution and the plastic molder is not performing commercial distribution, do they still need to register and list?