Winning with FDA: How to Manage a Successful 510(k) Device Submission

In order to secure approval of a medical device, a sponsor must use one of several pathways prescribed by the FDA. The primary avenues are the 510(k) clearance, the Pre-Market Approval (PMA) and the de novo submission. This post will focus on the most common pathway, the 510(k). Virtually all Class II medical devices are cleared via the 510(k) submission process. While the 510(k) process is the least complicated, sponsors sometimes find it obscure and difficult to navigate. We will explore the most effective strategies for securing a 510(k) clearance, with a focus on the needs of smaller companies that have less experience with this pathway. Read More ›