# 21 CFR § 812.5: Labeling of investigational devices

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-812.5

## Section

- **Citation:** 21 CFR § 812.5
- **Heading:** Labeling of investigational devices
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS > Subpart A—General Provisions

## Text

(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.”
(d) The appropriate FDA Center Director, according to the procedures set forth in § 801.128 or § 809.11 of this chapter, may grant an exception or alternative to the provisions in paragraphs (a) and (c) of this section, to the extent that these provisions are not explicitly required by statute, for specified lots, batches, or other units of a device that are or will be included in the Strategic National Stockpile.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980; 72 FR 73602, Dec. 28, 2007]

## Nearby sections

- [21 CFR § 812.1 § 812.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.1.md)
- [21 CFR § 812.2 § 812.2 Applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.2.md)
- [21 CFR § 812.3 § 812.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.3.md)
- [21 CFR § 812.5 § 812.5 Labeling of investigational devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.5.md)
- [21 CFR § 812.7 § 812.7 Prohibition of promotion and other practices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.7.md)
- [21 CFR § 812.10 § 812.10 Waivers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.10.md)
- [21 CFR § 812.18 § 812.18 Import and export requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.18.md)
- [21 CFR § 812.19 § 812.19 Address for IDE correspondence.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.19.md)
- [21 CFR § 812.20 § 812.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.20.md)
- [21 CFR § 812.25 § 812.25 Investigational plan.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.25.md)
- [21 CFR § 812.27 § 812.27 Report of prior investigations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.27.md)
- [21 CFR § 812.28 § 812.28 Acceptance of data from clinical investigations conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.28.md)
- [21 CFR § 812.30 § 812.30 FDA action on applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.30.md)
- [21 CFR § 812.35 § 812.35 Supplemental applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-812.5. Check the current official text before relying on it. Not legal advice.