What is Quality System 21 CFR Part 820?

FDA 21 CFR Part 820 is a regulatory framework governing the quality systems for devices regulated by the FDA in the United States, known as the Current Good Manufacturing Practice (CGMP). The CGMP specifications for Medical Devices are outlined in 21 CFR Part 820, finalized in the Federal Register on July 21, 1978. This regulation has been in effect since December 18, 1978, and is commonly referred to as Part 820.

It serves as a mandatory quality system regulation for the distribution of Medical Devices in the U.S.

The significance of implementing Quality System 21 CFR Part 820

The implementation of Quality System 21 CFR Part 820 is crucial for ensuring the excellence and safety of Medical Devices. By following these regulations, manufacturers establish comprehensive processes for designing, producing, packaging, labelling, storing, installing, and servicing finished devices. Compliance with these standards is essential to guarantee the effectiveness and safety of Medical Devices following the Federal Food, Drug, and Cosmetic Act.

Relationship with the registration of Medical Devices in the U.S.

The implementation of Quality System 21 CFR Part 820 is closely connected to the pre-market submission process for Medical Devices in the United States. While following these regulations is not a mandatory component of the documentation submission process for obtaining FDA approval or clearance, FDA can conduct audits at any point. These audits aim to assess the conformity of a manufacturer’s system with the specified quality standards.

It’s important to note that stringent requirements for the presence of Quality System 21 CFR Part 820 are not obligatory for products classified as Class I, lower-risk devices. Nevertheless, for devices in other risk classes, compliance with these regulations remains essential to ensure the lawful distribution and utilization of Medical Devices in the U.S. The FDA’s audit process serves as a proactive measure, allowing the agency to verify manufacturers’ ongoing compliance of manufacturers.

Failure to comply with these standards may result in various consequences, including warnings, product recalls, fines, and, in rare instances, legal consequences.

Connection with ISO 13485:2016

Quality System 21 CFR Part 820 is closely connected with ISO 13485:2016, especially following the revision of ISO 13485:2016 in 2016 and the alignment in 2018 of Part 820 with ISO 13485:2016. In 2018, the FDA announced its intention to harmonize Part 820 with 13485, meaning there are now fewer differences between the two. The main difference between the two is that in the US, ISO 13485:2016 is a voluntary standard that defines quality system requirements. Part 820 comes from the FDA, a federal agency, which means that non-compliance can result in action.

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