FDA publishes final guidance on Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

FDA publishes final guidance on Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Today, the FDA released the final guidance document “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” This guidance provides labeling and safety testing recommendations for medical devices that contain heparin.  The guidance is intended to help reduce heparin product overdose errors caused by misinterpretation of the expression of drug strength in product labeling. The FDA identified the way drug strength is expressed on injectable product labeling as a major factor in heparin product overdose errors. When dosed incorrectly, heparin products can cause serious patient injury or death. This guidance applies to medical devices and device-led combination products that include heparin sodium or low molecular weight heparin. The guidance clarifies FDA's current labeling and safety testing recommendations for heparin lock flush solution products and heparin-bonded products, as well as recommendations for safety testing for heparin-containing products. Further, the guidance clarifies that specific labeling for the amount and strength of heparin for heparin-bonded products is not generally needed. This guidance document also aligns FDA recommendations for these devices with the current United States Pharmacopeia (USP) monographs that outline quality standards for heparin. USP monographs help ensure the quality, safety, and benefit of drugs for patients, and alignment with updated monographs supports FDA efforts to protect public health. If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov. Food and Drug Administration Center for Devices and Radiological Health