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FDA guidance on adopting IEC standards to be out in next few months, CDRH's Jacobson says.

This article was originally published in The Gray Sheet

Executive Summary

FDA ADOPTION OF IEC 601-1-2 EMC STANDARD TO REFERENCE FIRST VERSION of the International Electrotechnical Commission's electromagnetic compatibility standard. Although the standard is in the process of being revised, FDA will recognize the original version published in 1993 and currently in force, Donald Witters, a staffer in the Office of Science and Technology in FDA's Center for Devices and Radiological Health, said June 12 at an FDA/Association for the Advancement of Medical Instrumentation (AAMI) meeting on EMC in Arlington, Virginia.

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