21 C.F.R. § 812.5 Labeling of investigational devices.
Title 21 - Food and Drugs
(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with §801.1), the quantity of contents, if appropriate, and the following statement: “CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.” The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions. (b) 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 purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects.” [45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]
Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart A—General Provisions
§ 812.5 Labeling of investigational devices.
