§ 801.16. Medical devices; Spanish-language version of certain required statements.
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/us/cfr/t21/s§ 801.16·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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).