Medical Device Labeling Requirements

This ICR collects information from manufacturers, importers, and distributors of medical devices to disclose to health professionals and consumers specific information about themselves or their devices on the label or labeling of their devices. The primary users of the information disclosed on the label or in the labeling of devices are the health professionals who use or prescribe the device or the lay consumers who use the device. The labeling should contain sufficient information for these persons to use the device safely and effectively. FDA may use the information to determine whether there is reasonable assurance of the safety and effectiveness of the device for its intended use.

The latest form for Medical Device Labeling Requirements expires 2021-10-31 and can be found here.

Processing, labeling, or repacking agreement--801.150(a)(2)

Federal Enterprise Architecture: Health - Consumer Health and Safety