Federal Register #FDA2026N6710

FDA Classifies Infant Supine Sleep System as Class II Medical Device

This FDA final order establishes a new regulatory classification for infant supine sleep systems: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Happiest Baby, Inc. is referenced as the requester for De Novo classification of the SNOO Smart Sleeper - Products/Services: - Infant supine sleep system (no specific part numbers or quantities listed) - Device intended to facilitate supine sleep for infants unable to roll over consistently - Unique/Notable Requirements: - Device classified as a class II medical device with special controls - Special controls include requirements for clinical data, human factors testing, biocompatibility, non-clinical performance testing, and specific labeling - Classification codified under 21 CFR Part 880 - Aims to reduce risk of SIDS/SUID and enhance patient access to innovative devices - No procurement, purchase, or award is being made; this is a regulatory classification action only

Description

This final order classifies the infant supine sleep system as a class II medical device with special controls. The device is intended to facilitate a supine sleep position for infants who cannot consistently roll over, reducing the risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID). The classification includes requirements for clinical data, human factors testing, biocompatibility, non-clinical performance testing, and specific labeling to ensure safety and effectiveness. The order aims to enhance patient access to innovative devices by reducing regulatory burdens.

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