Final answer:
Manufacturers that need to register with the FDA include domestic contract manufacturers following another's specifications without distributing devices, domestic manufacturers of devices under IDE, and foreign manufacturers selling devices in the US.
Step-by-step explanation:
The main answer to the question about which manufacturers must register their facility with the FDA includes Domestic (US) contract manufacturers who follow another person's specifications and do not commercially distribute the devices.Domestic manufacturer of a device being investigated under an Investigational Device Exemption (IDE).Foreign manufacturers shipping devices into the US for sale.An explanation for this is that the FDA requires registration to ensure they oversee the safety and performance of medical devices available in the US, which would include those manufacturers that produce devices under another's specifications as well as those involved in clinical investigations under an IDE. Additionally, foreign manufacturers must register because they are introducing devices into the US market. Component manufacturers who sell only to the device manufacturer using their components are not required to register.In conclusion, registration with the FDA is crucial for maintaining public health and safety by enabling the FDA to monitor and regulate the medical devices that are distributed in the US market.