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# FDA Publishes 3 X-Ray Guidances
- URL: https://www.fdaweb.com/fda-publishes-3-x-ray-guidances/
- Published: 2023-02-22T12:00:00.000Z
- Updated: 2026-09-14T18:16:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153830

FDA has published three guidances relating to x-ray systems. The first, *Performance Standards for Diagnostic X-Ray Systems and Their Major Components; Small Entity Compliance Guide*, is intended to assist small entities to comply with a 2005 final rule amending the performance standard for diagnostic x-ray systems and their major components. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-major-components-21cfr-102030-102031-102032?ref=fdaweb.com) also reflects a 1/20 amendment to the radiological health regulation removing certain reporting requirements for diagnostic x-ray systems and their major components.

The second guidance, *Assembler’s Guide to Diagnostic X-Ray Equipment*, addresses requirements that apply to diagnostic x-ray equipment under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-x-ray-equipment?ref=fdaweb.com) does not address requirements that apply to such equipment under the medical device provisions of the act.

*Medical X-Ray Imaging Devices Conformance with IEC Standards* describes the agency’s policy on the regulation of medical x-ray imaging equipment that is subject to the FFDCA and agency regulations that apply to medical devices and electronic products. FDA says it is using the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards?ref=fdaweb.com) to harmonize performance standards in the FFDCA with International Electrotechnical Commission standards, where appropriate, to help ensure more efficient and consistent regulatory review of submissions for the products. It also provides recommendations to industry on how to comply with the applicable requirements.