The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
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The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
COVID-19 requires us to rethink our current device disinfection procedure.
It is the first federal approval for a test that uses saliva as the primary test biomaterial for COVID-19.
Advanced Sterilization Products received an EUA for the STERRAD Sterilization Cycles.
The system will allow healthcare professionals to reuse the critical care products up to 20 times during the COVID-19 pandemic.
Diagnostic companies are hustling to increase availability of testing.