F.D.A. Plans to Intensify Oversight of Heart Devices
April 7, 2006 09:20

April 7, 2006 By BARRY MEIER

The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says....

Dr. Schultz said, "We recognize that we need to do a better job and that we need to do a better job in leveraging outside expertise. This seemed like a logical first step in doing that."...

Officials of Medtronic and St. Jude said they were awaiting the publication of the group's report before commenting on it. A spokesman for Boston Scientific, which agreed earlier this year to acquire Guidant, said recently that the company was considering which of the Guidant panel's recommendations to adopt.