Federal Register: FDA Reclassifies Over-the-Counter Sleep Apnea Risk Assessment Devices to Expand Patient Access
October 31, 2026
October 31, 2026
WASHINGTON, Oct. 31 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II. The special controls that apply to the device typ . . .
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Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II. The special controls that apply to the device typ . . .