21 C.F.R. § 801.16 Medical devices; Spanish-language version of certain required statements.
Title 21 - Food and Drugs
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).
Title 21: Food and Drugs
PART 801—LABELING
Subpart A—General Labeling Provisions
§ 801.16 Medical devices; Spanish-language version of certain required statements.
