CDRH Issues Final Orders on Six Device Classifications

CDRH has issued final orders reassigning classifications for six types of medical devices.

The orders, aimed at cutting burdens associated with premarket applications, cover several categories of device, including those indicated for neurology, ophthalmology, surgery and anesthesiology.

The orders consolidate five device types under class II and one under class I. The five devices grouped into class II include the thermal vestibular for headache, the intranasal electrostimulation device for dry-eye symptoms, the positive airway pressure delivery system, the hemostatic device for intraluminal gastrointestinal use and the positive airway pressure delivery system.