Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Administration Staff; Availability
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."
Abstract as published in the Federal Register.
See the structure of SPEQ’s reviewed analysis
Explorer members can open three bounded, human-reviewed previews each month. Full relationships, analysis, and implementation implications remain protected.
Sign in free to preview →The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.