Source: https://www.law.cornell.edu/cfr/text/21/801.16
Timestamp: 2017-04-30 09:16:41
Document Index: 601397577

Matched Legal Cases: ['art 801', '§ 801', '§ 801', '§ 321', '§ 342', '§ 343', '§ 351', '§ 352', '§ 355', '§ 360', '§ 360', '§ 371', '§ 374', 'art 801']

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 801 › Subpart A › Section 801.16 21 CFR 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). This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 321 - Definitions; generally§ 342 - Adulterated food§ 343 - Misbranded food§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 355 - New drugs§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings§ 374 - Inspection
Title 21 published on 13-Apr-2017 03:05The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 801 after this date.2017-03-20; vol. 82 # 52 - Monday, March 20, 201782 FR 14319 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments