SOCRA CCRP Practice Exam

What additional controls are Class II devices subject to beyond those for Class I?

1. Premarket approval

2. Special controls

3. Clinical trials

4. Advanced performance standards

The correct answer is: Special controls

Class II devices are defined as medium-risk devices that require special controls in addition to the general controls required for Class I devices. These special controls may include performance standards, post-market surveillance, patient registries, and other measures to ensure the safety and effectiveness of the device. Therefore, options A, C, and D would not be additional controls for Class II devices as they may already fall under the category of general controls for Class I devices. In contrast, special controls are specifically required for Class II devices to ensure their safety and efficacy.