What are the requirements for medical device labeling?

Medical device labeling is a critical aspect of ensuring safe and effective use of medical devices and is subject to specific requirements by regulatory bodies like the FDA. Labeling encompasses all written, printed, or graphic material accompanying the device, including the device itself, its packaging, and any accompanying documents like instructions for use. Key requirements include the manufacturer's name and address, allowing users to identify the responsible party. The device's intended use must be clearly stated, describing the specific medical conditions or purposes for which the device is indicated. Instructions for use must be provided in a clear and understandable manner, explaining how to properly use the device, including any necessary precautions or warnings. Contraindications, warnings, and precautions must be prominently displayed to alert users to potential hazards or limitations associated with the device's use. The device's lot number or serial number must be included for traceability and to facilitate recalls if necessary. Expiration date, if applicable, must be clearly marked to ensure that the device is not used beyond its shelf life. Storage and handling instructions must be provided to ensure that the device is stored and handled properly to maintain its integrity and functionality. Any symbols used on the label must be explained in accordance with recognized standards. For reusable devices, instructions for cleaning and sterilization must be provided to prevent infection. Specific labeling requirements may vary depending on the device's classification and intended use. Compliance with labeling requirements is essential for ensuring that users have the information they need to use medical devices safely and effectively.