{"data":{"id":"us/21-cfr-801.16","jurisdiction":"us","citation":"21 CFR 801.16","heading":"Medical devices; Spanish-language version of certain required statements.","body":"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).","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"e67340ac2f3afaee2c366a874a535d0bc7574815cbbb6972ddb69a3eb8cf3fc7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-801.15","next":"us/21-cfr-801.18"},"notice":"GroundRules: Original legal text. Not legal advice."}