Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment." This draft guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray systems and their major components. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of "electronic products," as defined in FDA regulations. This draft guidance, when finalized, will supersede FDA's guidance entitled "Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment." This draft guidance is not final nor is it in effect at this time.