Diagnostic x-ray equipment performance standard; request for comments and information--FDA. Advance notice of proposed rulemaking.
The Food and Drug Administration (FDA) is announcing its intention to propose amendments to the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to address changes in the technology and use of radiographic and fluoroscopic systems. The agency is issuing this advance notice of proposed rulemaking (ANPRM) in accordance with its policy of early public disclosure of rulemaking activities. The FDA is soliciting comments and information from interested persons concerning the subject matter of the proposed amendments.
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D005471:Fluoroscopy / Q000295:instrumentation* / Q000592:standards; D011859:Radiography / Q000295:instrumentation* / Q000592:standards; D013679:Technology, Radiologic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration