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

FAQs

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

CFR Part 820 content is being added. Stay tuned.

What is meant by 21 CFR?

CFR Part 820 content is being added. Stay tuned.

What does CFR stand for?

CFR Part 820 content is being added. Stay tuned.

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