Medical Devices

How to Report a Problem or Complaint

Prompt reporting of problems with bed rails can help the CPSC and FDA identify and better understand the risks associated with these products. If you have had a problem with bed rails, we encourage you to file a report through CPSC for consumer products, at www.SaferProducts.gov or call CPSC's Hotline at (800) 638-2772, or to the FDA’s MedWatch web site for medical devices.

How do I know if a bed rail is a medical device or a consumer product so I can report the incident to the correct agency?

Both the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) have regulatory authority for bed rails. The FDA oversees medical devices and the CPSC oversees consumer products. Medical devices are intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body. If medical claims are included, these products are generally regulated as medical devices by the FDA.

Adult portable bed rails that do not include medical claims are regulated as consumer products by CPSC. For example, adult portable bed rails intended to be applied only to beds not regulated by FDA and for which no medical or other disease-mitigation claims are made are generally regulated by CPSC.

Check the intended use on the product label, accompanying labeling, promotional material, advertising and any other relevant source to help determine if it is a consumer product or a medical device.

Page Last Updated: 11/03/2014
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