Labeling: Regulatory Requirements for Medical Devices

摘要

The publication is Chapter 6 of the Regulatory Requirements for Medical Devices - A Workshop Manual. It covers labeling requirements that device manufacturers, reconditioners, repackers, and relabelers must consider when a product requires labeling. Such labeling may include adequate instructions for use, servicing instructions, adequate warning against uses that may be dangerous to health, or information that may be necessary for the protection of users.