21 C.F.R. § 801.16

Current through October 31, 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