eCFR Reference Browser

---

title: "21 CFR §801.16"

source: "https://www.ecfr.gov/current/title-21/section-801.16"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "801"

part_subject: "LABELING"

subpart_code: "A"

subpart_subject: "General Labeling Provisions"

section_number: "801.16"

section_subject: "Medical devices; Spanish-language version of certain required statements."

cfr_reference: "21 CFR 801.16"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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).

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