Is The Medical Device Review System Flawed?

Law360, New York (August 1, 2011, 1:14 PM EDT) -- At the request of the United States Food and Drug Administration, the Institute of Medicine appointed a committee to review the process under which medical devices are analyzed for reasonable assurances of safety and effectiveness as required by the Federal Food, Drug and Cosmetic Act (FFDCA). Manufacturers of medical devices that may have a moderate risk to patients cannot market the devices until the devices make their way through the 510(k) process — a reference to Section 510(K) of the FFDCA....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!