Electronic products; performance standard for diagnostic x-ray systems and their major components. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
D003365:Costs and Cost Analysis; D019719:Diagnostic Equipment / Q000592:standards; D004582:Electronics, Medical / Q000331:legislation & jurisprudence / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D005471:Fluoroscopy / Q000295:instrumentation / Q000592:standards*; D006801:Humans; D015994:Incidence; D007394:International System of Units; D009369:Neoplasms / Q000209:etiology / Q000401:mortality; D011829:Radiation Dosage; D011830:Radiation Effects; D011839:Radiation, Ionizing; D011859:Radiography / Q000295:instrumentation / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration