E-mailContent: The investigational device or its immediate package shall bear a label with the following
information:
- Name and place of business of the manufacturer, packager, or distributor of the device;
- Quantity of contents, if appropriate
- The statement, "CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use."; and
- A description (i.e., on the immediate label or other labeling) of all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.Prohibitions: The labeling of an investigational device shall not bear any statement that is false or misleading in any particular and shall not represent that the device is safe or effective for the purpose for which it is being investigated.