- Yes, you can list each of the applicable device and identify the ABC Company as a "Manufacturer" as well as a "Specification Developer". You can see in the image below for such kind of dual responsibilities.
View attachment 26946
The XYZ company will need to register as a "Contract Manufacture" and list each type of your device they manufacture for you. They will also need to maintain the registration by paying the annual fee every year until you discontinue that particular device from commercial distribution.
NO, they don't need a new 510(k) to list your device, they can simply provide your 510(k) number for the device, list your device and identify the XYZ company as the "Contract Manufacturer".
NO, the device manufactured at the XYZ facility is already a "Finished Device" by FDA definition. Look at the FDA definition of "Finished device" below;
21 CFR 820.3(l): Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
So, the XYZ company must register their facility, pay the fee for registration, list your device and maintain the registration every year by paying the annual fee. However, if the XYZ company is manufacturing the devices only for the ABC company and if the ABC company wants then it is possible for the ABC company to pay the registration fee for the XYZ company. In that case, the ABC company will need to pay double of the Registration fee every year but there is no restriction in it.
By the way, the XYZ company will be visited by the FDA for Auditing purposes once the XYZ company register their facility.