RAC Medical Devices Practice Exam 2025 – Comprehensive Test Prep

In a 510(k) submission, to establish that a device is "substantially equivalent" to a predicate device, it must demonstrate the same intended use and similar technological characteristics. This means that the new device should perform the same function and be designed in a comparable manner to the predicate device that is already on the market, ensuring that it is safe and effective for the intended population.

The focus on the intended use highlights the need for the new device to serve the same purpose and address the same medical condition as the existing device. Additionally, similar technological characteristics refer to the underlying technologies used in the device, which should be either the same or very similar, indicating that any differences do not affect safety or effectiveness. This is a foundational concept in the regulatory pathway for medical devices, allowing manufacturers to bring new products to market efficiently while maintaining safety and efficacy standards.