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Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern

 
• By Elizabeth Orr

By clearing Happiest Baby’s SNOO bassinet in March, the US FDA exercised authority over a product that typically would fall within the jurisdiction of consumer product safety regulators. One law firm questions what that might mean for manufacturers of similar products.

Baby sleeps in a co-sleeper cradle attached to her parents' bed.
• Source: Shutterstock

Some fear that the US Food and Drug Administration’s clearance of an infant bassinet that promises to encourage safer sleep may bring unforeseen consequences to other developers of sleep-related products by expanding the agency’s definition of “medical device.”

On 30 March, the FDA issued a de novo clearance for Happiest Baby’s SNOO Smart Sleeper Bassinet with an indication...

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