Regulatory Affairs Certification (RAC) Practice Exam

How does FDA require that all device registration and listing information be submitted?

1. FDA Forms 2891 and 2892

2. FDA Forms 2656 and 2657

3. FDAs Unified Registration and Listing System

4. FDA Form 3356

The correct answer is: FDAs Unified Registration and Listing System

The correct answer is based on the requirement that device registration and listing information must be submitted through the FDA’s Unified Registration and Listing System (URLS). This system provides a streamlined and efficient way for manufacturers and suppliers to register their medical devices and submit necessary listing information. The URLS is an online platform that ensures consistency and up-to-date data management for device registrations, aligning with the FDA's goals for modernizing regulatory processes. Using the URLS is crucial for compliance with FDA regulations and for maintaining accurate and current records regarding which devices are on the market. This system centralizes the data and allows for easier access by both the regulators and the industry, improving overall efficiency. Other options listed refer to various forms or systems that do not represent the current method mandated by the FDA for device registration and listing. While those forms might have historical significance or pertain to other regulatory submissions, they are not the correct method for submitting registration and listing information as required by the FDA today.