RAC Study Guide 2026

Proactive post-market surveillance involves activities initiated by the manufacturer to actively search for information about a device's performance, rather than waiting for events to be reported. A customer survey is a method of actively seeking out this information. Investigating complaints, submitting vigilance reports, and issuing corrections are all reactive measures taken in response to an identified issue or event.

A New Drug Application (NDA) is a comprehensive submission to the FDA requesting approval to market a new drug in the U.S. It must include all data and information about the drug, including results from all clinical trials (safety and efficacy), detailed manufacturing processes, quality control information, and proposed labeling. The NDA demonstrates that the drug is safe and effective for its intended use.

Fast Track designation is an FDA program designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. This designation allows for more frequent communication with the FDA and, potentially, a rolling review of the application, aiming to get important new drugs to patients sooner.

21 CFR 211.22 explicitly states that the Quality Control Unit shall have the responsibility and authority to approve or reject all components and drug products. While the QCU reviews and approves other documents and activities, the final authority to release or reject a batch rests solely with them.

The core of a 510(k) submission is to demonstrate that the new device is 'substantially equivalent' to a legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. This means the new device is at least as safe and effective as the predicate.

The primary purpose of a Q-Submission is to obtain feedback from the agency to guide product development and submission preparation. Therefore, including clear, specific, and well-reasoned questions is the most critical component, as these questions will frame the entire discussion and the feedback provided by the FDA. The other elements, while potentially part of the overall package, are secondary to the core goal of getting answers to specific regulatory, technical, or clinical questions.