Final answer:
Under the Federal Food, Drug, and Cosmetic Act, General Controls include Establishment Registration, Quality System Regulation, and Device Listing, but not Pre-market Approval Application, which is a more specific control for medical device safety and effectiveness.
Step-by-step explanation:
The question involves identifying which item is not considered a General Control under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The correct answer here is option B) Pre-market Approval Application. The General Controls for medical devices, according to the act and the oversight by the Center for Devices and Radiological Health, include Establishment Registration, Quality System Regulation, and Device Listing. Pre-market Approval is a more specific form of FDA oversight and is not classified as a General Control, but rather a specific type of control for certain medical devices that ensures their safety and effectiveness before they can be marketed. This process involves evidence submission to demonstrate the safety and effectiveness of a new device, which differs from the general controls that primarily pertain to the registration and listing processes.