FDA's New Draft Guidance on Medical Device Changes and the 510(k)

7 September 2011, Wilmington, United States

Introduction

This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).