Promoting Your 510(k) – Pending Device: 5 Questions About FDA’s Policy

October 13, 2016By: Jeffrey K. Shapiro Download PDF

A 510(k) submission rather than a 510(k) clearance is the threshold that a device firm needs to meet to being advertising or displaying a product under a long-established, one-sentence agency policy. But important questions remain about proper application of this policy by the Industry. This article will answer those questions.