FDA Says No More Approval or Notification Requirements for Restless Leg Syndrome Treatment
The Food and Drug Administration is reclassifying nonpowered lower extremity pressure wraps as Class I devices that are not subject to premarket approval or notification requirements. The order codifies a reclassification that took effect Dec. 30, 2013, said FDA. The devices remain subject to prescription-use restrictions, it said.
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
(Federal Register 07/03/14)