The Food and Drug Administration (FDA) is classifying the infant supine sleep system 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 infant supine sleep system. 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.
US Federal Register - FDA Rules · June 26, 2026
FDA Classification of Infant Supine Sleep System as Class II Medical Device
Original title: Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
FDA classifies infant supine sleep systems as Class II devices subject to special controls to ensure safety and effectiveness.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.