Fda labeling medical device. Labeling encompasses all written materials including labels, packaging, instructions for use, and promotional materials. The FDA is strict about labeling claims on medical devices. . Aug 15, 2025 · FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where applicable), and device-specific requirements. Apr 9, 2025 · Expiration date means the date by which the label of a device states the device must or should be used. Medical device labeling includes all materials accompanying a device—labels, manuals, brochures, and even advertising. FDA, we, or us means the Food and Drug Administration. As defined by the Food Drug and Cosmetic Act (FDCA), medical device labeling extends beyond the printed label on the device and will cover all the device’s accompanying brochures, manuals (IFU), marketing materials, and website content. Finished device means any device or accessory to any device that is suitable for use or capable of functioning. May 18, 2025 · This guide walks through the core components of FDA medical device labeling, required content, regulatory expectations, and best practices for maintaining control and compliance. The Medical devices marketed in the United States, whether manufactured here or imported from abroad, must comply with the labeling requirements; if the labeling of a medical device does not comply with FDA regulations or requirements, it will be considered misbranded. This publication explains label and labeling regulations and requirements for medical devices. Learn FDA requirements under 21 CFR Part 801 to ensure accurate, compliant communication and avoid misbranding risks. fyt vwatr ebgz vsfrueja pmlauglz xwxcpxu xfeu jilax qlylmwn des