Which of the following is NOT included in general controls for Class I devices?

General controls for Class I devices are fundamental regulatory requirements established by the FDA to ensure the safety and effectiveness of medical devices. Class I devices are typically considered to have a low risk to patients and users, so the regulations governing them are less stringent compared to those for higher-risk classes of devices.

Suitable for intended use, being properly labeled, and adequately packaged are all part of the general controls that apply to these devices. Suitable for intended use ensures that the device functions as expected and meets the design specifications set forth by the manufacturer. Proper labeling is critical, as it provides clear instructions and information for safe operation and use. Adequate packaging protects the device from contamination and physical damage during shipping and handling, helping to ensure that it arrives to the user in a safe and effective condition.

In contrast, undergoing extensive clinical trials is not a requirement for Class I devices. This process is more characteristic of Class III devices, which require premarket approval due to their higher risk levels. Clinical trials are designed to provide substantial evidence of safety and effectiveness, which is not a general requirement for the majority of Class I devices. Therefore, the option regarding extensive clinical trials stands out as not being included in general controls for Class I devices.