Information for Manufacturers of Bed Rail Products
Some manufacturers may not be aware that marketing a bed rail intended to cure, treat, or prevent a disease or condition designates their product as a medical device. Medical devices are regulated by the FDA.
Bed rails intended for a medical purpose would be subject to regulation by the FDA. Examples include a device intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed and repositioning, intended to reduce risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions. These products are medical devices subject to FDA regulation, and the manufacturer must comply with applicable FDA medical device regulations.
For an overview of medical devices and some basic information about device regulation, visit the Overview of Medical Devices Regulation.
Adult bed rails marketed without medical intended uses are subject to regulation by the Consumer Product Safety Commission (CPSC). For more information on the CPSC's requirements for bed rails, see CPSC.gov.
Recommendations for Manufacturers
Manufacturers of adult portable bed rails should refer to ASTM F3186-17: Standard Specification for Adult Portable Bed Rails and Related Products. This FDA-recognized voluntary consensus standard establishes performance criteria for adult portable bed rails, including resistance to entrapment.
Images using the entrapment test probe as outlined in ASTM F3186-17 are shown below.
Additional guidance for testing can be found in the Guidance for Industry and FDA Staff - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. The FDA recommends that you follow ASTM F3186-17.
The FDA recommends that you review your current labeling, packaging, and advertising for intended uses to cure, treat, or prevent a disease or condition. Examples include adult portable bed rails intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed or repositioning, intended to reduce risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions.
Manufacturers of hospital bedrails should also refer to the FDA-recognized voluntary consensus standard, IEC 60601-2-52, Medical electrical equipment which applies to the basic safety and essential performance of medical beds for adults.
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.
See Device Registration and Listing | FDA.
If your Adult Portable Bed Rails is a medical device, you must register your place of business and list your device with FDA. The product code is QTC Adult Portable Bed Rails for Medical Purposes. Alternatively, you may revise your labeling, packaging, and promotion and advertising materials to ensure your products are not marketed, promoted, or advertised as medical devices.
If you are a manufacturer and you are not sure if your bed rail product is a medical device, please check Device Advice: Device Regulation and Guidance.
If you have questions about what to do in order to seek FDA approval or clearance for your medical device, contact the Division of Industry and Consumer Education (DICE) at 1-800-638-2041 or via email at DICE@fda.hhs.gov.