What is Title 21 CFR Part 820 (CFR Part 820)?

Title 21 CFR Part 820 Definition

The U.S. FDA stipulates that manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products are known as current good manufacturing practices (CGMPs). These practices ensure that life sciences companies comply with applicable laws and regulations. 21 CFR Part 820 is intended to ensure devices entering the marketplace are safe and effective.

Source: https://www.fda.gov


What is the difference between ISO 13485 and 21 CFR 820?

ISO 13485:2016 is a standard based upon ISO 9001:2008 and is specific to the design and manufacture of medical devices. This standard is projected to be adopted by the Food and Drug Administration (FDA) in the near future. Currently, 21 CFR Part 820 is the quality system regulation used by the FDA to outline good manufacturing practices for medical devices.

*Source: https://13485store.com

What is meant by 21 CFR?

The Code of Federal Regulations (CFR) is a compilation of the general and permanent rules published by the Executive departments and agencies of the federal government in the Federal Register. The Food and Drug Administration’s rules are found in Title 21 of the CFR.

*Source: https://www.fda.gov

What does CFR stand for?

CFR stands for Code of Federal Regulations.

*Source: https://www.fda.gov

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.