FDA Wants Tougher Scrutiny Of Emergency Defibrillators

Law360, New York (March 22, 2013, 2:07 PM EDT) -- The U.S. Food and Drug Administration on Friday proposed a stricter approval process for emergency defibrillators, including those already on the market, in hopes of cutting down on widespread device failures during often-fatal cardiac arrests.

The agency's action follows dozens of recalls and 45,000 cases over the past eight years in which defibrillators didn't perform as intended, likely contributing at least slightly to the 92 percent death rate for the 300,000 Americans whose hearts stop beating outside of a hospital setting each year.

A variety of...
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