Regulatory Affairs Certification (RAC) Practice Exam

The process that allows a manufacturer to request FDA review of a new medical device is the Premarket Notification, commonly known as 510(k). This process is designed for devices that are substantially equivalent to one or more legally marketed devices. When a manufacturer submits a 510(k), they provide evidence to demonstrate that their device is safe and effective based on the comparison to an already approved device.

One of the advantages of the 510(k) process is that it often requires less rigorous testing than other pathways, such as Pre-market Approval (PMA), which mandates a more comprehensive review due to the potential risks associated with the device. The 510(k) pathway is commonly used for devices that are considered lower risk, allowing for a more streamlined route to market.

In addition to 510(k), there are other regulatory pathways like the Investigational Device Exemption (IDE) and Clinical Trial Application (CTA), but these are typically used for devices in the investigational stage or those undergoing clinical trials, rather than for the initial review for market entry. Therefore, 510(k) is the specific mechanism utilized for initiating the FDA review for many new medical devices seeking to demonstrate substantial equivalence.