1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 801 - LABELING
  6. Subpart A - General Labeling Provisions
  7. 21 CFR § 801.16
21 CFR § 801.16
Medical devices; Spanish-language version of certain required statements
June 25, 2020
CFR

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).

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§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling
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§ 801.18 Format of dates provided on a medical device label

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