FDA regulatory requirements for medical devices with control algorithms

Discusses how the US Food and Drug Administration (FDA) regulates medical devices that include an automatic control system. First, the context of FDA regulation is given. It is indicated how the FDA regulates control systems, so that a device developer may develop an idea of when the device is subject to FDA regulation, what steps he can follow to comply with FDA regulations, and what process he needs to follow when conducting tests and clinical trials. During the life cycle of a medical device, the Federal Government takes on several roles. The role of the FDA is distinguished from those of other parts of government. Then, information is presented on the following topics: the quality system regulation and design control requirements, the developer's responsibilities when using human subjects, the process for premarket clearance and approval, requirements for registration and listing if the company plan to distribute the device, good manufacturing practices and FDA inspections, and post-approval and reporting requirements.