21 CFR 820 – An Overview

CGMP requirements for Medical devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act as per section under 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation came into effect on December 18, 1978, and was codified under part 820. All Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems applicable for FDA-regulated food, drugs, biologics, and medical devices are known as current good manufacturing practices.

In short, FDA 21 CFR Part 820, also known as the Quality System Regulation QSR which outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use and sale in the United States Of America. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure QSR compliance.

Video about 21 CFR 820 basics

Link to FDA 21 CFR 820 Guidelines

There is no Certification process for 21 CFR 820 / QSR. FDA does not require certification, only compliance with the standards is recommended. They will, however, inspect your facility at some point where your organization is registered and products are listed and available in the US Market so that in effect is a "certification" if you pass.

There are lots of similarities between ISO 13485 and CFR 820, if you comply with ISO 13485; you would be very close to 21 CFR Part 820. Read More >>

GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Many countries regulate pharmaceutical and medical device industry by insisting to follow GMP procedures and have their own criteria that correspond with their legislations.

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