A recent article published by MedTech, “Could Bassinet Clearance Expand FDA Authority? Law Firm Expresses Concern,” quotes a Crowell client alert and Crowell attorney, Robbie Jost, on this development. According to the client alert, “To the extent the FDA considers the SNOO a medical device based on its intended impact on infant sleep position, many other sleep products could also fall within this, or a similar, category-e.g., pillows intended to position the head to reduce snoring, pillows intended to be used by pregnant women to enable a comfortable sleep position, or even simply mattresses of different firmness intended to support the body in different ways.” But will this occur? “Short of a similarly situated manufacturer deciding to go for FDA clearance,” Jost says, “I don’t think that the FDA would exercise jurisdiction over other products just because they’re similar to the SNOO.” “[But] in theory, this [clearance] could lead other manufacturers of similar types of consumer products to seek clearance from the FDA to market them as medical devices.” “If manufacturers decide to go to the FDA and seek clearance and the FDA gives that clearance, the FDA will be more of a stakeholder in the regulatory landscape,” she said. “I just can’t predict whether other manufacturers will follow.”
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