Code of Federal Regulations · Section

§ 801.16 — Medical Devices; Spanish-language Version Of Certain Required Statements

21 C.F.R. § 801.16

View:

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. § 801.15 21 C.F.R. § 801.18

Authorizing Statute