# 21 CFR § 801.6: Medical devices; misleading statements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-801.6

## Section

- **Citation:** 21 CFR § 801.6
- **Heading:** Medical devices; misleading statements
- **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 801—LABELING > Subpart A—General Labeling Provisions

## Text

Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.

## Nearby sections

- [21 CFR § 801.1 § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.1.md)
- [21 CFR § 801.3 § 801.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.3.md)
- [21 CFR § 801.4 § 801.4 Meaning of intended uses.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.4.md)
- [21 CFR § 801.5 § 801.5 Medical devices; adequate directions for use.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.5.md)
- [21 CFR § 801.6 § 801.6 Medical devices; misleading statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.6.md)
- [21 CFR § 801.15 § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.15.md)
- [21 CFR § 801.16 § 801.16 Medical devices; Spanish-language version of certain required statements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.16.md)
- [21 CFR § 801.18 § 801.18 Format of dates provided on a medical device label.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.18.md)
- [21 CFR § 801.20 § 801.20 Label to bear a unique device identifier.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.20.md)
- [21 CFR § 801.30 § 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.30.md)
- [21 CFR § 801.35 § 801.35 Voluntary labeling of a device with a unique device identifier.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.35.md)
- [21 CFR § 801.40 § 801.40 Form of a unique device identifier.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.40.md)
- [21 CFR § 801.45 § 801.45 Devices that must be directly marked with a unique device identifier.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.45.md)
- [21 CFR § 801.50 § 801.50 Labeling requirements for stand-alone software.](https://www.frixlaw.com/law-library/statutes/ecfr-21-801.50.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-801.6. Check the current official text before relying on it. Not legal advice.