Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; 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 a final guidance entitled "Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment." This guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of an "electronic product" as defined in FDA regulations. This guidance supersedes FDA's 1989 guidance entitled "Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment."