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: Tags: Regulatory and Compliance IVD Source Type: news