South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What class of devices requires FDA approval before marketing?

1. Class I

2. Class II

3. Class III

4. Class IV

The correct answer is: Class III

Class III medical devices require FDA approval before they can be marketed. This approval process, known as Premarket Approval (PMA), is necessary due to the higher risk associated with these devices. Class III devices are typically those that support or sustain life, are implanted in the body, or pose a potential unreasonable risk of illness or injury. The rigorous FDA review process ensures that these devices are safe and effective for their intended use. Manufacturers must provide significant evidence from clinical studies demonstrating the device's effectiveness and safety before they can receive approval. In contrast, Class I devices are generally low-risk and typically only require general controls to ensure safety and effectiveness. Class II devices, while they pose a moderate risk, often require clearance through the 510(k) process, which demonstrates that the device is substantially equivalent to a device already on the market. Class IV is not a recognized classification; there are only Class I, Class II, and Class III as established by the FDA. This helps clarify the significance of Class III and its requirement for pre-market approval.