What does the term 'labeling' encompass in the context of medical devices?

The term 'labeling' in the context of medical devices has a well-defined and broad scope that includes any written, printed, or graphic information that accompanies the device. This encompasses not only the labels affixed to the medical device itself but also any packaging materials and instructions for use. Labeling serves to inform users and potential users about the proper use of the device, its indications, contraindications, warnings, and precautions, which are essential for ensuring safety and effectiveness.

By including any form of written or graphic information, labeling supports regulatory compliance and provides critical information to both healthcare professionals and patients. This definition aligns with regulatory requirements set forth by authorities like the FDA, which emphasize the importance of comprehensive and clear labeling to facilitate proper device use. This thorough understanding of labeling ensures that users have access to crucial information that can influence patient outcomes and device safety.