Regulatory Affairs Certification (RAC) Practice Exam

A manufacturer can submit an Abbreviated 510(k) based on which of the following?

1. A Recognized clinical guidelines

2. B Relevant consensus standards

3. C Historical data from previous studies

4. D Manufacturer’s proprietary research

The correct answer is: B Relevant consensus standards

A manufacturer can submit an Abbreviated 510(k) based on relevant consensus standards because this pathway is specifically designed to leverage existing standards that have been recognized by the FDA. The Abbreviated 510(k) process allows manufacturers to demonstrate that a new device is as safe and effective as a predicate device by referencing consensus standards, which are developed by organizations recognized by the FDA, such as the International Organization for Standardization (ISO) or the American National Standards Institute (ANSI). These standards provide a validated framework for assessing the performance and safety of medical devices and can include testing methods, technical specifications, and other criteria that help ensure compliance with regulatory requirements. By utilizing relevant consensus standards, manufacturers can streamline the submission process and facilitate faster approval while still ensuring that safety and efficacy benchmarks are met. While recognized clinical guidelines, historical data from previous studies, and proprietary research can be useful in the overall product development and evaluation process, they do not directly align with the specific provisions of the Abbreviated 510(k) submission pathway as effectively as relevant consensus standards do. These alternatives may not provide the same level of assurance or regulatory acceptance by the FDA that consensus standards offer.