FDA classifies infant supine sleep systems as Class II medical devices
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The Food and Drug Administration has officially classified a category of products known as “infant supine sleep systems” into Class II. This ruling covers devices designed to keep infants in a flat, back-sleeping position, such as the SNOO Smart Sleeper, which was the specific product that triggered this classification process.
Why it matters: This action reduces regulatory hurdles for companies making infant sleep aids, potentially speeding up the availability of new products. It also establishes clear safety expectations regarding securement and positioning to lower the risk of sudden infant death syndrome or other injuries associated with improper use.
Who it affects
- Manufacturers of infant sleep systems and related wearable devices
This final order was issued by the Food and Drug Administration; readers should consult the full Federal Register document for detailed technical requirements.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document