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) .
21 CFR Part 801 · Labeling
§ 801.16 Medical devices; Spanish-language version of certain required statements
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FDA guidance that cites § 801.16
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 6896 13 Feb 1976