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

---
identifier: "/us/cfr/t21/s801.16"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.16 - Medical devices; Spanish-language version of certain required statements."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.16"
section_name: "Medical devices; Spanish-language version of certain required statements."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "801"
part_name: "LABELING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.16 Medical devices; Spanish-language version of certain required statements.

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).