FDA Proposes Exempting Medical Devices from Premarket Notification

Published
  • August 01 2014, 11:50am EDT

The U.S. Food and Drug Administration has issued new draft guidance that would exempt certain Class I and II medical devices from premarket submission requirements.

The FDA has identified certain Class II medical devices for which the regulatory agency believes a 510(k) review is not necessary to assure safety and effectiveness before these devices enter the marketplace, and certain Class I medical devices which it believes no longer meet the “reserved” criteria of the Federal Food, Drug, and Cosmetic Act .

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access

Comments