Product Lines - Toxic Torts and Product Liability Insights - Issue 3, 2018

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....

Please see full Newsletter below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Spilman Thomas & Battle, PLLC | Attorney Advertising

Written by:

Spilman Thomas & Battle, PLLC
Contact
more
less

Spilman Thomas & Battle, PLLC on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.