FDA Set To Bump Defibrillators Up In Risk Class
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...
To view the full article, register now.