SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

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Question: 1 / 400

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

Premarket approval

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.

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Clinical trials

Advanced performance standards

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