What is typically required for Class III devices before market approval?

For Class III medical devices, premarket approval (PMA) is typically required before they can be marketed. This process is essential because Class III devices are often associated with a higher risk to patients and require a thorough evaluation of their safety and effectiveness. The PMA process involves the submission of detailed information to the FDA, including clinical data demonstrating that the device is safe and effective for its intended use.

In contrast, general controls alone are insufficient for Class III devices due to their complexity and risk factors. Performance standards may be relevant for some medical devices, but they do not replace the necessity of a comprehensive PMA for Class III items. Additionally, the 510(k) clearance process is primarily applicable to devices that can be shown to be substantially equivalent to an already legally marketed device, which does not meet the more stringent requirements of Class III devices. Thus, obtaining premarket approval is a critical step for ensuring that such devices meet the high standards demanded for safety and efficacy before reaching the market.