What does the term "labeling" encompass for medical devices?

The term "labeling" for medical devices encompasses all information provided with the device, which includes instructions for use, safety information, and promotional materials. This comprehensive definition is crucial because effective labeling ensures that users, healthcare providers, and regulatory bodies understand the device's intended purpose, proper use, safety precautions, and potential risks.

Labeling is not limited to just packaging or only regulatory submissions; it includes various forms of communication that accompany a device. This broader understanding aligns with regulatory requirements, which stipulate that all relevant information must be available to ensure safe and effective use. By incorporating instructions and promotional materials, the labeling serves as an essential tool for education and risk management in the context of medical devices.