What is the primary purpose of 21 CFR 814?

The primary purpose of 21 CFR 814 is to establish the regulations for Premarket Approval (PMA) of medical devices. This section outlines the process that manufacturers must follow to obtain FDA approval before marketing certain high-risk medical devices. The PMA process is more rigorous than other regulatory pathways, as it requires manufacturers to provide extensive scientific evidence to demonstrate the safety and effectiveness of a device.

21 CFR 814 specifies the types of information that must be included in a PMA application, including clinical data, manufacturing processes, labeling, and other relevant details. By adhering to these regulations, the FDA ensures that medical devices are subject to thorough review before they can be commercialized, ultimately protecting public health and safety.

This regulation plays a critical role in the regulatory framework governing medical devices by establishing the necessary safeguards for high-risk devices, which is distinct from the other choices that focus on different aspects of product regulation or entirely different product categories.