![]() are required to register annually with the FDA. Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. Manufacturers of hospital bedrails should also refer to the FDA-recognized voluntary consensus standard, IEC 6, Medical electrical equipment which applies to the basic safety and essential performance of medical beds for adults. 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. The FDA recommends that you review your current labeling, packaging, and advertising for intended uses to cure, treat, or prevent a disease or condition. The FDA recommends that you follow ASTM F3186-17. Images using the entrapment test probe as outlined in ASTM F3186-17 are shown below.Īdditional guidance for testing can be found in the Guidance for Industry and FDA Staff - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. This FDA-recognized voluntary consensus standard establishes performance criteria for adult portable bed rails, including resistance to entrapment. Manufacturers of adult portable bed rails should refer to ASTM F3186-17: Standard Specification for Adult Portable Bed Rails and Related Products. For more information on the CPSC's requirements for bed rails, see. These products are medical devices subject to FDA regulation, and the manufacturer must comply with applicable FDA medical device regulations.įor an overview of medical devices and some basic information about device regulation, visit the Overview of Medical Devices Regulation.Īdult bed rails marketed without medical intended uses are subject to regulation by the Consumer Product Safety Commission (CPSC). 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. Medical devices are regulated by the FDA.īed rails intended for a medical purpose would be subject to regulation by the FDA. ![]() 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.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |