A Comprehensive Guide to COVID-19 EUA Submissions
Links for additional information:
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency
Additional frequently asked questions about COVID-19 EUAs, including questions specific to clinical laboratories and questions specific to test kit manufacturers
If you have additional questions for FDA contact the Division of Microbiology Devices at 301-348-1778 or email CDRH-EUA-Templates@fda.hhs.gov
Source: MDDI - Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance IVD Source Type: news
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