FDA Labeling Requirements for Medical Devices

FDA labeling requirements for medical devices define the essential elements that must be present on the label. These include the device name, intended use, instructions, warnings, precautions, and potential risks. Labels should also include manufacturing information, such as production and expiration dates, so only current and viable devices are available on the market. Labels also help guide healthcare professionals and patients in the device's handling, storage, and administration. Furthermore, as consumers demand digital records, manufacturers may move to electronic Information for Use (eIFU) inserts to provide easy access to product information. 

Vision inspection systems can help manufacturers and distributors maintain FDA adherence to medical device label requirements by automatically verifying that required elements are present and accurately printed on the label. They use cameras and software to inspect labels for defects or inconsistencies such as incorrect or missing information, physical defects, or illegible barcodes. This confirms that the label meets FDA requirements, preventing the risk of costly recalls or non-compliance penalties. Additionally, label inspection systems can verify that eIFU QR codes are readable, validate unique serial numbers for traceability, and generate detailed documentation for regulatory audits.