FDA Proposals Clarify Rules For Devices With Predicates

By Lina Kontos, Kristin Zielinski Duggan and Kelliann Payne (October 24, 2023, 6:20 PM EDT) -- Last month, the U.S. Food and Drug Administration Center for Devices and Radiological Health issued three new draft guidances as part of an effort to modernize its Section 510(k) program for new products that can be found substantially equivalent to existing, marketed predicate devices....

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!