# 21 CFR § 801.20: Label to bear a unique device identifier

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-801.20

## Section

- **Citation:** 21 CFR § 801.20
- **Heading:** Label to bear a unique device identifier
- **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 B—Labeling Requirements for Unique Device Identification

## Text

(a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter.
(2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter.
(b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions.
[78 FR 58818, Sept. 24, 2013]

## 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-21-801.20. Check the current official text before relying on it. Not legal advice.