FDA proposes tightening rules for heart defibrillators
March 22 (Reuters) - The U.S. Food and Drug Administration is proposing new rules that would require makers of emergency defibrillator systems to conduct clinical trials before receiving marketing approval.
The proposals follow reports of a rising number of instances in which the devices, used by paramedics and others to deliver electrical shocks to people whose hearts suddenly stop beating, have malfunctioned.
The FDA plans to announce its proposed rules later today. The proposal was published on Friday morning in the Federal Register.
(Reporting By Toni Clarke in Washington; Editing by Gerald E. McCormick)
March 22- The U.S. Food and Drug Administration is proposing new rules that would require makers of emergency defibrillator systems to conduct clinical trials before receiving marketing approval. The FDA plans to announce its proposed rules later today. The proposal was published on Friday morning in the Federal Register.