Assembler’s Guide to Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff

The Center for Devices and Radiological Health (CDRH) is charged with the responsibility for enforcing regulations created under the Radiation Control for Health and Safety Act of 1968 (Public Law 90-602) (the Act). The Act was later moved to the Federal Food, Drug, and Cosmetic Act (FD&C Act) with the passage of the Safe Medical Devices Act of 1990, in a new section entitled Electronic Product Radiation Control (EPRC), under Subchapter V – Part C. The regulations written under the Act are covered in 21 CFR Chapter I, Subchapter J, and the Diagnostic X-ray Performance Standards for Electronic Products.
These regulations cover the manufacturing, importing, and installation of equipment that emits electronic product radiation to achieve its intended purpose or as a by-product of meeting its intended purpose. Specific regulations under “Diagnostic x-ray systems and their major components” (21 CFR 1020.30), “Radiographic equipment” (21 CFR 1020.31), “Fluoroscopic equipment” (21 CFR 1020.32), and “Computed tomography (CT) equipment,” (21 CFR 1020.33) cover aspects of the performance of each listed type of equipment and place specific requirements on the manufacturers, importers, dealers, distributors, and assemblers of the covered equipment. The term “Performance Standards” will be used in this document to refer to these regulations collectively known as the Performance Standards for Diagnostic X-ray Systems and Their Major Components. This document addresses only requirements that apply to diagnostic x-ray equipment under the EPRC provisions of the FD&C Act. This document does not address requirements that apply to such equipment under the medical device provisions of the FD&C Act. As a part of the requirements under the Performance Standards, manufacturers of diagnostic x-ray equipment that is used on human patients must comply with all applicable requirements in the Performance Standards covered in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33.They must also affix labels to their products that declare they are certifying those products to meet the regulations (21 CFR 1010.2).
Many diagnostic x-ray systems consist of components from different manufacturers while other systems use components from a single manufacturer. Whether these systems comply with the Performance Standards is dependent upon proper installation and final testing of the complete system at the user location, which FDA considers the final step in the manufacture of these systems. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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