Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 801 - LABELING
Subpart A - GENERAL LABELING PROVISIONS
Section 801.16 - Medical devices; Spanish-language version of certain required statements

21 C.F.R. § 801.16

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Current through September 30, 2024
Section 801.16 - Medical devices; Spanish-language version of certain required statements

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 C.F.R. §801.16