Regulatory Affairs Certification (RAC) – Devices Practice Exam 2025 - Free Practice Questions and Study Guide

In a premarket submission, a device that is used as a benchmark for comparison to establish the safety and effectiveness of a new device is referred to as a predicate device. This term is crucial in the context of the 510(k) submission process, where the new device must demonstrate that it is substantially equivalent to a legally marketed predicate device in terms of intended use, technological characteristics, and performance.

The concept of a predicate device is central to regulatory pathways, particularly in the U.S. Food and Drug Administration (FDA) regulatory framework, as it allows manufacturers to leverage existing safety and efficacy data from already approved devices, thereby facilitating the approval process for new devices. Understanding the role of predicate devices is key for those involved in regulatory affairs, as it underpins the necessity for comprehensive comparative analysis during the submission process.

The other terms mentioned do have specific meanings but do not apply in this context. A comparator device is more commonly used in clinical studies to test against a new intervention; a predecessor device often refers to an earlier version of a device rather than one that is legally marketed and used for comparison; and a substantially equivalent device is a characterization of the relationship to the predicate rather than the name of the device itself. Understanding these distinctions is essential for professionals