What is the purpose of labeling requirements under the FDA?

The purpose of labeling requirements under the FDA is fundamentally to ensure that necessary safety and use information is provided to consumers and healthcare professionals. This requirement is critical as it helps to inform users about the medical device's intended use, potential hazards, instructions for use, and any necessary precautions. By mandating detailed labeling, the FDA aims to promote safe and effective use of medical devices, reducing the risk of misuse or adverse events that could arise from lack of information.

The inclusion of accurate labeling also helps to comply with regulatory standards, promoting transparency and reliability in the medical device industry. This ultimately supports the overall goal of protecting public health by ensuring that users have access to essential information that informs their decisions regarding the use of medical devices.