Revising FDA 510(k) Poses Challenges For Device Makers

By Patricia Kaufman and Joel Schwartz (December 12, 2018, 2:03 PM EST) -- The U.S. Food and Drug Administration's Section 510(k) process, by which a medical device manufacturer can bring a product to market based on the premise that the proposed device is substantially equivalent to an already legally marketed "predicate device," has been viewed as a streamlined pathway to market when compared to more rigorous evidentiary requirements of premarket approval. Critics, however, have cited patient safety issues allegedly caused by the "lower" standards needed for 510(k) clearance. ...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!


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!