FDA Set To Bump Defibrillators Up In Risk Class

Law360 (January 26, 2011, 4:40 PM EST) -- The U.S. Food and Drug Administration has decided there should be stricter controls on heart defibrillators, in response to thousands of individual complaints about safety problems.

At a meeting on Tuesday, a majority of the advisory committee members indicated that they would support bumping defibrillators up to Class III high-risk medical devices from Class II medium-risk devices. There was no formal vote, however, FDA representatives said.

Class III devices require FDA approval in the form of a premarket approval application.

In November, the FDA called for...
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