Zdrowie i gospodarka · 10.12.2002
Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
The Food and Drug Administration (FDA) is proposing to amend the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to update the standard to account for changes in technology and use of radiographic and fluoroscopic systems as well as to fully utilize the currently accepted metric system of units in the standard. For clarity and ease of understanding, FDA is republishing the complete contents of the affected regulations. 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).