IDE Sponsor Responsibilities - Labeling

Under an investigational device or its immediate package must bear a label with the following information:

• the name and place of business of the manufacturer, packer, or distributor;
• the quantity of contents, if appropriate; and
• the statement, "CAUTION Investigational device. Limited by Federal (or United States) law to investigational use."

The label must also describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

The sponsor should provide detailed information on device labeling in the investigational protocol. This information may vary depending on the device and the nature of the study.

Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.