WHY, WHEN AND WHAT ALL ABOUT 21 CFR

21 CFR refers to the Code of Federal Regulations Title 21, which is a set of regulations established by the United States.

Food and Drug Administration (FDA) to ensure the safety and efficacy of food, drugs, and medical devices. Here is a brief view of 21 CFR:

Established year: 1977

Responsibility: United States Food and Drug Administration (FDA)

Authorized country: United States of America

Role: To ensure the safety and efficacy of food, drugs, and medical devices

Why 21 CFR mandatory: 21 CFR is mandatory to ensure that food, drugs, and medical devices sold in the United States are safe, effective, and properly labeled.

Who owns 21 CFR: United States Food and Drug Administration (FDA)

The parts of 21 CFR include:

Part 1 - General

Part 50 - Protection of Human Subjects

Part 54 - Financial Disclosure by Clinical Investigators

Part 56 - Institutional Review Boards

Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

Part 312 - Investigational New Drug Application

Part 314 - Applications for FDA Approval to Market a New Drug

Part 600 - Biological Products: General

Part 601 - Licensing

Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

Part 820 - Quality System Regulation

Part 860 - Medical Device Classification Procedures

A brief point-wise preview of some of the chapters of 21 CFR:

Part 50 - Protection of Human Subjects: This part outlines the requirements for the protection of human subjects involved in clinical trials.

Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General: This part outlines the requirements for the manufacturing, processing, packing, and holding of drugs to ensure their safety and efficacy.

Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals: This part outlines the requirements for the manufacturing of finished pharmaceuticals to ensure their safety and efficacy.

Part 312 - Investigational New Drug Application: This part  outlines the requirements for the submission of an Investigational New Drug Application (IND) to the FDA for approval of clinical trials on new drugs.

Part 820 - Quality System Regulation: This part outlines the requirements for the establishment of a quality system to ensure the safety and efficacy of medical devices.

Part 860 - Medical Device Classification Procedures: This part outlines the procedures for the classification of medical devices based on their level of risk.

In conclusion, 21 CFR is a set of regulations established by the FDA to ensure the safety and efficacy of food, drugs, and medical devices sold in the United States. It is mandatory to ensure that products sold in the United States are safe, effective, and properly labeled. The various parts of 21 CFR outline the requirements for various aspects of product development and manufacturing to ensure compliance with FDA regulations.

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