Department of Health and Human Services, Food and Drug Administration: Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
GAO-05-843R: Jun 23, 2005
- Full Report:
GAO reviewed the Department of Health and Human Services, Food and Drug Administration's (FDA) new rule on performance standards for diagnostic x-ray systems. GAO found that (1) the rule amends the federal performance standard for diagnostic x-ray systems and their major components 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; and (2) FDA complied with all applicable requirements in promulgating the rule.