§ 801.16 Medical devices; Spanish-language version of certain required statements.
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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
This text was captured on Sep 22, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.
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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).
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