Source: https://www.law.cornell.edu/cfr/text/21/820.40
Timestamp: 2017-01-23 19:31:37
Document Index: 664906492

Matched Legal Cases: ['art 820', '§ 820', '§ 351', '§ 352', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 374', '§ 381', '§ 383', 'art 820', 'art 820']

21 CFR 820.40 - Document controls. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 820 › Subpart D › Section 820.40 21 CFR 820.40 - Document controls.
§ 820.40 Document controls.
Each manufacturershallestablish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following: (a)Document approval and distribution. Each manufacturershall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use. (b)Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturershall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. 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§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360d - Performance standards§ 360e - Premarket approval§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 360l - Postmarket surveillance§ 371 - Regulations and hearings§ 374 - Inspection§ 381 - Imports and exports§ 383 - Office of International Relations
Title 21 published on 2015-12-03The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 820 after this date.2016-04-25; vol. 81 # 79 - Monday, April 25, 201681 FR 24041 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Extension of Comment Period
21 CFR 820.50 — Purchasing Controls.
21 CFR 820.70 — Production and Process Controls.
21 CFR 820.181 — Device Master Record.
21 CFR 820.186 — Quality System Record.
Title 21 published on 2015-12-03.No entries appear in the Federal Register after this date, for 21 CFR Part 820.