Posts Tagged pma

What Makes A Device Class III? FDA Proposes New Language To Clarify

Monday, March 31st, 2014 | Permalink

FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.

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What Makes A Device Class III? FDA Proposes New Language To Clarify

FDA tightening watch of AEDs | theheart.org

Friday, March 22nd, 2013 | Permalink

In addition to AEDs, there are 26 other medical devices that came to market prior to 1976, and the FDA is in the process of deciding which of those devices will now require a PMA. In its review, the FDA decided that AEDs …

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FDA tightening watch of AEDs | theheart.org