Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea
Key claim: FDA is placing over-the-counter devices that assess sleep-apnea risk into class II with special controls, so makers can market them under a lighter path than full premarket approval.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea 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 over-the-counter device to assess risk of sleep apnea. 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
FDA’s classification of OTC sleep-apnea risk assessment devices into Class II with special controls lowers the regulatory bar for consumer-facing screening products, potentially expanding at-home options for identifying people who should pursue formal apnea evaluation. The action is part of a broader pattern of FDA using Class II special controls to streamline market entry for lower-risk novel devices.