# 21 CFR § 801.18: Format of dates provided on a medical device label

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-801.18

## Section

- **Citation:** 21 CFR § 801.18
- **Heading:** Format of dates provided on a medical device label
- **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

(a) In general. Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: The year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.
(b) Exceptions. (1) A combination product that properly bears a National Drug Code (NDC) number is not subject to the requirements of paragraph (a) of this section.
(2) If the device is an electronic product to which a standard is applicable under subchapter J of this chapter, Radiological Health, the date of manufacture shall be presented as required by § 1010.3(a)(2)(ii) of this chapter.
[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-21-801.18. Check the current official text before relying on it. Not legal advice.