What are Medical Device 510k Submissions?
A 510(k) is a Premarket Notification for medical devices submitted to the FDA. It’s demonstrate that the device is as safe and effective for human use as the legally marketed device that is not subjected to Pre-market Approval (PMA). 510(k) refers to section 510(k) of the Federal Food, Drug and Cosmetic Act (FD & C Act). The FDA 510(k) program allows manufacturers to submit premarket notification (PMN) applications to the agency in order to market new products that are substantially equivalent to existing approved products. It takes careful evaluation, effective collaboration, and diligent accuracy to file a successful document with the U.S. Food and Drug Administration (FDA). Submitting a 510(k) can be a complex process, and it’s important to make sure you have all the necessary information ready before submitting. In this guide, you’ll find out what questions to ask, what documents to prepare, and how to make sure your submission is compliant.