Drugs and Devices

The Medical Device Amendments (MDA) to the Food Drug and Cosmetics Act contain an express preemption provision, namely 21 U.S.C. ' 360k(a), which prohibits states from imposing requirements different from, or in addition to, the specific federal requirements imposed on medical devices by FDA regulations. However, the U.S. Supreme Court has held, in a case involving ' 360k(a), that traditional state law claims are permissible and are not preempted if the common law duties involved parallel the duties statutorily imposed in the federal law and do not impose higher standards.

26 minute read December 21, 2007 at 01:43 PM
By
Janice G. Inman
Drugs and Devices

The Supremacy Clause of the U.S. Constitution provides that the 'Laws of the United States … shall be the supreme Law of the Land.' U.S. Const. Art. VI, cl. 2.

This premium content is locked for LawJournalNewsletters subscribers only

ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN LawJournalNewsletters

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

Already have an account? Sign In Now

For enterprise-wide or corporate access, please contact Customer Service at [email protected] or call 1-877-256-2473.

NOT FOR REPRINT

© 2026 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.

Continue Reading

Most firms are aiming their newest tools at the work they already do — pouring their most powerful technology into running the same tasks a little faster. But when everyone automates the same tasks at once, no one pulls ahead. That reaches the future a little faster while leaving a firm’s largest opportunity untouched — and that opportunity isn’t doing more of the existing work, but transforming how the high-value work gets done.

June 01, 2026

Artificial intelligence is rapidly embedding itself into legal workflows, but much of the conversation treats all use cases as if they carry the same level of risk, even if they do not. The more useful question is not whether AI works, but where it can be safely applied and where it cannot.

June 01, 2026