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

Article preview from "The Gray Sheet"- March 24, 2014

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.

 

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

Article preview from "The Gray Sheet"- March 24, 2014

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 should be class III and require a PMA, or whether an understanding of risks and how they might be controlled could allow such products to be downclassified to class II or I.

A proposed rule scheduled for publication March 25 attempts to address this confusion with the introduction of five newly defined categories that describe situations when a class III designation will always be necessary.

The five proposed class III categories are:

• Devices that present known risks that cannot be controlled
• Devices for which the risk-benefit profile is unknown or unfavorable
• Devices for which a full review of manufacturing information is necessary
• Devices for which pre-market review of any change affecting safety or effectiveness is necessary
• Combination products which have a device primary mode of action, but which require a finding that a drug constituent is safe and effective (or that a biologic is safe, pure and potent)

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