CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 801—LABELING > SUBPART A—General Labeling Provisions (§801.1 to §801.16) > 801.16—Medical devices; Spanish-language version of certain required statements.

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).