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QUOTED. 10 March 2020. Emma Spaulding.

Executive Summary

US regulators provided more specific recommendations on thermal damage testing for electrosurgical devices in an updated final guidance. See what US FDA's spokeswoman Emma Spaulding said about it here.

"FDA has received many questions from sponsors regarding appropriate testing conditions for assessing thermal damage for electrosurgical devices for general surgery." – Emma Spaulding, spokeswoman, US FDA

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