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CFR - Code of Federal Regulations Title 21 Subpart A - General Provisions. Subpart B - Organization and Personnel. Subpart C - Buildings and Facilities. Subpart D - Equipment. Subpart E - Control of Components and Drug Product Containers and Closures. Subpart F - Production and Process Controls.
Title 21 CFR Part 11 establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. It is a portion of Title 21 of the Code of Federal Regulations.
This subpart clarifies the application of current good manufacturing practice regulations to combination products, and provides a regulatory framework for designing and implementing the current good manufacturing practice operating system at facilities that manufacture co-packaged or single-entity combination products.
It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis. Each title is divided into chapters, which usually bear the name of the issuing agency.
FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nations food supply (human and animal), cosmetics, and products that emit radiation.
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10 parts of 21 CFR medical device manufacturers must know Part 820 - Quality System Regulation (QSR): This is often referred to as the Good Manufacturing Practices (GMP) regulation for medical devices.
The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.
A full set of the CFR consists of approximately 200 volumes. The approximately 200 CFR volumes are revised at least once a year on a quarterly basis as follows: Titles 1 -- 16 as of January 1. Titles 17 -- 27 as of April 1.

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