21 CFR 801.16 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Labeling (§ 801.1 To § 801.437) — General Labeling Provisions (§ 801.1 To § 801.18) — Medical devices; Spanish-language version of certain required statements.
4 Aug 2016
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).