Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion
Key claim: The FDA is classifying external mechanical stimulators for congestion relief as Class II medical devices, subjecting them to specific special controls to ensure safety and effectiveness.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the external mechanical stimulator for the relief of congestion into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external mechanical stimulator for the relief of congestion. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
Why this matters
This final rule establishes Class II regulatory requirements, including device-specific special controls, for external mechanical stimulators used to relieve congestion. It addresses device safety and effectiveness requirements for manufacturers, rather than establishing insurance coverage or changing patient cost-sharing.