SOCRA CCRP Practice Exam

What does a Class II device require for FDA notification?

1. A detailed report of its chemical composition

2. FDA 510(k) clearance

3. An advanced user manual

4. Clinical trial results

The correct answer is: FDA 510(k) clearance

A Class II device is a type of medical device that poses a moderate risk to human health, as classified by the Food and Drug Administration (FDA). In order for a Class II device to be sold and distributed in the United States, it must first go through FDA 510(k) clearance. This involves submitting a premarket notification to the FDA, which includes information such as the device's intended use, performance data, and comparison to predicate devices. This clearance shows that the device is substantially equivalent to a device that has already been legally marketed and therefore is considered safe for public use. Option A is incorrect because a detailed report of chemical composition is required for Class III devices, which pose a higher risk. Option C is incorrect because an advanced user manual is not specific to Class II devices and is instead a general requirement for all medical devices sold in the US. Option D is incorrect because, while clinical