21 CFR 801.16
§ 801.16 Medical devices; Spanish-language version of certain required statements.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 801.16, § 801.16 Medical devices; Spanish-language version of certain required statements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88658
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Full 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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.