Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
Key claim: The FDA is classifying the oropharyngeal electrical stimulator as a Class II medical device subject to special controls to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator 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 oropharyngeal electrical stimulator. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of 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
Class II classification with special controls establishes a defined 510(k) regulatory pathway for oropharyngeal electrical stimulators, which are used in dysphagia rehabilitation. This lowers market-entry barriers for manufacturers compared with Class III premarket approval, potentially expanding provider and patient access to these devices for swallowing disorders.