Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues.

For this edition, we are reporting on several important and timely legal issues. As you will see, we strive to make these e-blasts both informative and valuable by having our attorneys comment on WHY these issues are important and how they could affect your business....

The Rise of Use of Medical Devices Force FDA to Change the Rules -

"In an ever-changing healthcare landscape, FDA seeks a new procedure that will let the market continue to develop but also offer a safe environment for the users."

Why this is important: Through the De Novo Classification Proposed Rule, the FDA aims to modernize the pathway for the review of new, low- to moderate-risk medical devices for which there are no legally marketed predicate devices. If finalized, the proposed rule would establish certain procedures and criteria used in the De Novo classification process, providing market applicants with a better understanding of how to navigate the certification process. Additionally, the proposed rule would establish a 120-day review period....