GroundRules
21 CFR 801.16: Medical devices; Spanish-language version of certain required statements.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 801—LABELING
- Subpart A—General Labeling Provisions
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).
Collected 2026-08-27T02:24:47Z. Source file · JSON