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FDA Categorizes Devices as Class II

August 23, 2016

The FDA had made determinations on de novo requests for classification.

Micro Interventional Devices’ Permaseal, indicated for soft tissue approximation of cardiac apical tissue during transcatheter value replacement, will be deemed a Class II device, the FDA said, which is the classification the company had requested on June 25.

Class II devices require special controls to provide reasonable assurance of safety.

Sommetrics’ cNEP Airway Management System was classified as a Class II device, despite a de novo request for Class I. The airway management system is a silicone rubber collar that is attached to the neck and provides negative suction through a regulated vacuum source to provide a patient airway during mild to moderate sedation. — Tamra Sami

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