FDA 21 CFR Part 820 Quality System Regulation Test Standard for Medical Devices

EUROLAB laboratory provides testing and compliance services within the scope of FDA 21 CFR Part 820 standard. The requirements in this section govern the methods and facilities used and controls used for the design, manufacture, packaging, labeling, storage, installation and service of all finished devices for human use.

The purpose of the requirements in this section is to ensure that finished devices are safe, effective and otherwise compliant with the Federal Food, Drug, and Cosmetic Act. This section sets out the basic requirements that apply to manufacturers of finished medical devices.

If a manufacturer is only engaged in some operations subject to the requirements in this section and not in others, that manufacturer must comply only with the requirements applicable to the operations in which it operates. This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use the appropriate provisions of this regulation as a guide.

FDA regulations apply to manufacturers of finished devices that distribute commercial medical devices. According to 21 CFR 820, a finished device is defined as "any device or accessory for any device suitable for use or capable of functioning, whether or not packaged, labeled or sterilized".

The blood tube and diagnostic x-ray components are considered finished devices by the FDA. This is because they are accessories for finished devices, so an accessory manufacturer must meet FDA regulations.

EUROLAB assists manufacturers with FDA 21 CFR Part 820 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.