Information for Manufacturers of Bed Rail Products
Some manufacturers may not be aware that marketing a bed rail with claims to cure, treat, or prevent a disease or condition designates their product as a medical device. Medical devices are regulated by the FDA.
Any bed rail manufacturer that makes a medical claim such as mitigating disease or restoring lost function would be subject to regulation by FDA. Examples include a manufacturer labeling its bed rails to assist impaired individuals in performing daily activities or to mitigate the effects of Parkinson’s disease, Alzheimer’s, multiple sclerosis or other medical conditions. These products would be medical devices subject to FDA regulation, and the manufacturer would need to 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 and Their Regulatory Pathways.
Adult bed rails marketed without medical claims are subject to regulations by the Consumer Product Safety Commission (CPSC). For more information on the CPSC and its regulatory authority, visit www.cpsc.gov.
Recommendations for Manufacturers
Manufacturers of hospital bed rails should refer to the voluntary international standard IEC 60601-2-52 Medical Bed, which applies to the basic safety and essential performance of medical beds for adults.
The FDA recommends that you review your current labeling, packaging, and advertising for any direct or implied claims to cure, treat, or prevent a disease or condition.
If your labeling, packaging, or advertising (including print and online) contains medical claims and you have failed to register and list your device with FDA, you are in violation of the Federal Food, Drug, and Cosmetic Act.
In order to comply with FDA regulations you must immediately:
- Stop marketing your products with these claims until you have registered your place of business and listed your device with FDA; or
- Change your labeling, packaging, or advertising to remove all medical claims and 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 Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or via email at email@example.com.