Zdrowie i gospodarka · 10/10/2019

FDA Releases Final Guidance on Labeling of Medical Devices with Lubricious Coatings

The Food and Drug Administration (FDA) has released a final guidance document titled "Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations" to provide labeling recommendations for medical devices with lubricious coatings used in the bloodstream. The guidance aims to enhance the consistency of information and promote safe use of these devices in clinical settings.