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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 September 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2018-D-4115
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health

FDA is issuing this guidance to provide clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines diagnostic x-ray systems as both a medical device and an electronic product, therefore these systems are subject to the provisions of the FD&C Act that apply to both medical devices and to electronic products, and their implementing regulations. This guidance document only addresses the requirements that apply to diagnostic x-ray equipment under the electronic product provisions of the FD&C Act and the regulations implementing those provisions. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of electronic products. It does not address requirements that may apply to diagnostic x-ray equipment as medical devices. This guidance supersedes FDA's guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2018-D-4115.

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