FDA classifies external mechanical stimulator for congestion as class II
A final order has been issued to place the device for relieving congestion into category II, adding special controls. The action is intended to provide reasonable assurance of safety and effectiveness and to enhance patients' access to innovative devices by reducing regulatory burdens.
Primary source
Federal Register rule, November 6, 2026
Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion
Read the source: Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion federalregister.gov
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