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Office of Compliance and Field Operations’ Enforcement Guidance Concerning CPSC Mattress Set Rule for Mattress Sets that are Medical Devices Regulated by the Food and Drug Administration

Mattress sets that are medical devices regulated as such by the Food and Drug Administration (“FDA”) do not need to comply with the flammability requirements of 16 CFR part 1633. This is a very narrow exemption that applies only if the mattress set is a medical device. Simply making medical claims for a mattress set does not take it out of the scope of 16 CFR part 1633. FDA advises that the sale of FDA regulated beds and mattresses are restricted to licensed health care professionals and medical institutions, such as hospitals and nursing homes. A patient needs a prescription from a licensed health care professional to purchase or lease a bed or mattress. These mattresses cannot be sold to the public through department stores, chain or specialty bedding stores without a prescription. In addition, mattress manufacturers would need to fully comply with all applicable FDA medical device regulations, prior to selling any mattresses intended for medical purposes.

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