What is a requirement for Class II devices to ensure safety and effectiveness?

For Class II devices, the requirement that includes both general and special controls is essential to ensure their safety and effectiveness. This is important because Class II devices typically have a moderate level of risk associated with their use, and therefore, the regulatory framework is designed to provide adequate oversight.

General controls encompass the basic requirements for all medical devices, such as proper labeling, establishment registration, and adherence to good manufacturing practices. However, Class II devices often require additional special controls to address their specific risks and to provide evidence that they meet the necessary safety and effectiveness standards. This can include specific performance standards, post-market surveillance, and the requirement of premarket notifications (510(k) submissions), among others.

In contrast, the other options do not provide the requisite framework for ensuring the safety and effectiveness of Class II devices. General controls alone lack the additional safeguards required for moderate-risk devices. Only requiring clinical trials would not be sufficient since not all Class II devices necessitate such rigorous testing, and claiming that no controls are needed would significantly compromise patient safety and device efficacy.