# 21 CFR § 801.16: Medical devices; Spanish-language version of certain required statements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-801.16

## Section

- **Citation:** 21 CFR § 801.16
- **Heading:** Medical devices; Spanish-language version of certain required 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

If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under § 801.15(c).

## 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-21-801.16. Check the current official text before relying on it. Not legal advice.