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GUIDANCE DOCUMENT

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Guidance for Industry and Food and Drug Administration Staff December 2018

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of In Vitro Diagnostics and Radiological Health

This draft guidance provides clarification to industry and FDA staff of the Federal Regulations that relate to diagnostic x-ray systems and their major components. This draft guidance, when finalized, will supersede FDA’s guidance entitled “Clarification of Radiation Control Regulations for 19 Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989). For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.