What must a device's labeling include according to FDA regulations?

Labeling for medical devices according to FDA regulations must be comprehensive and provide crucial information that ensures safe and effective usage by consumers and healthcare providers. This includes instructions for use, which guide users on how to properly operate the device; indications for use, explaining the conditions or situations for which the device is intended; warnings, which inform users of potential risks and side effects; and contraindications, indicating any conditions or patient populations for whom the device should not be used.

This comprehensive approach not only helps to inform but also protects users, reducing the likelihood of misuse or adverse events. The inclusion of such detailed information is vital for compliance with FDA regulations and is essential for maintaining safety standards in medical practice.

Other options do not meet the regulatory requirements; for instance, merely stating the price and manufacturer information does not provide any guidance on safe device use. A marketing strategy outline is unrelated to labeling requirements and does not convey necessary technical or safety information to users. Limiting labeling to product expiration dates lacks the critical details needed for effective and safe usage of the device.