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Month: June 2020

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents As a result of the Coronavirus Disease 2019 (COVID-19) pandemic and under the authority of section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA has issued numerous Emergency Use Authorizations (EUAs) for medical devices intended to […]
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