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# IEC Standards Conformance Guidance Out
- URL: https://www.fdaweb.com/iec-standards-conformance-guidance-out/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136365

FDA has issued a draft guidance, *Medical X-Ray Imaging Devices Conformance with IEC Standards*, to harmonize performance standards under the Federal Food, Drug, and Cosmetic Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help ensure streamlined regulatory review for submissions for medical x-ray imaging equipment. The [draft](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTYwODAyLjYyMjAzOTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDgwMi42MjIwMzk2MSZkYXR&ref=fdaweb.com) also gives industry recommendations on how to comply with the applicable requirements.

“FDA believes industry conformance to certain IEC standards would provide the same level of or improved protection of the public health and safety from electronic radiations as certain EPRC (Electronic Product Radiation Control) regulatory standards,” the guidance says. “FDA also believes conformance to certain IEC standards would be sufficient to meet the 510(k) premarket notification requirement for certain devices.”