Regulatory Affairs Certification (RAC) Practice Exam

For a device substantially equivalent to one marketed before 1976, which regulatory path should a company follow?

1. Premarket approval

2. 510(k)

3. Investigational Exemption

4. New Device Application

The correct answer is: 510(k)

A device that is substantially equivalent to one that was marketed before 1976 falls under the category of existing devices that were not subject to the modern premarket approval process. The 510(k) pathway allows manufacturers to demonstrate that their new device is as safe and effective as a similar device already on the market, specifically one that can be traced back to the pre-1976 grandfathered devices. This option is advantageous because it typically involves less rigorous requirements compared to premarket approval, which is a more extensive process used for devices that pose higher risks. The 510(k) submission focuses on the comparison of the new device to a predicate device, rather than requiring the extensive data on safety and effectiveness that premarket approval demands. By following the 510(k) process, a company can more quickly bring its device to market while ensuring compliance with regulatory standards, making it the appropriate regulatory path given the circumstances of substantial equivalence to a pre-1976 device.