A product issue could lead to serious health consequences, including loss of consciousness, bleeding, fluid buildup around the heart and death.
Although transactions were down, they exceeded more than $450 million last month.
The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
The Abbott ID NOW test may return false negative results.
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The prescription-only diagnostic allows patients to self-collect saliva samples to test for SARS-CoV-2.
Launched by AdvaMed, the platform was developed in collaboration with partners that include the Aerospace Industries Association and Google.
The hope is that healthcare workers would be able to reuse masks for a longer period of time.
It is the first federal approval for a test that uses saliva as the primary test biomaterial for COVID-19.