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

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.

FDA is proposing new regulatory language to better explain what types of devices should be designated to the most significantly regulated class III category and are not suitable for down-classification.

The agency says stakeholders have frequently been confused about whether or not the designation “high risk” means that a device...

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