Why Should You Attend: In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The recommendations are not official guidance yet as they will be open to public comment, and there are in excess of 70 proposed changes that, taken together, could result in a significant disruption to a program that has served patients well for more than 30 years. Following the public comment period CDRH said it will announce which recommendations it will implement as well as the projected timelines for implementation.This 520(k) webinar will address both sides of the proposed changes. We will discuss how the expected change will affect device makers in terms of additional cost, affect on number of devices cleared, what is the regulatory process for implementing the changes. We will also discuss what industry has to prepare for the statutory changes coming in 2011.