Regulatory Affairs Certification (RAC) Practice Exam

What is the most suitable route of submission for a Class II device with electrical components?

1. A Pre-market approval (PMA)

2. B Traditional 510(k)

3. C Abbreviated 510(k)

4. D Investigational Device Exemption (IDE)

The correct answer is: C Abbreviated 510(k)

For a Class II device with electrical components, the most suitable route of submission is often the Abbreviated 510(k). This submission pathway is designed for devices that demonstrate substantial equivalence to an existing device but may include modifications or new technological features. The Abbreviated 510(k) submission allows manufacturers to provide a more streamlined submission process by referencing existing information or guidelines established for similar devices, which is particularly beneficial for devices with established precedents in the market. The logic behind selecting the Abbreviated 510(k) involves the requirement for demonstrating compliance with specific regulatory criteria, such as special controls, that may apply to the electrical components. These controls can include safety and effectiveness data, which may already be available in the literature or from predicate devices. The other routes of submission, such as Pre-market Approval (PMA), are generally reserved for Class III devices that pose a higher risk to patients and require a more extensive demonstration of safety and efficacy. A Traditional 510(k) may also be valid, but the Abbreviated 510(k) is often preferred due to its efficiency for devices that meet the criteria for this pathway. An Investigational Device Exemption (IDE) is specifically for devices being tested in clinical trials, making it unsuitable