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FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
The market is expected to grow at a CAGR of 3.21 percent from 2021 to 2028 and reach $17.432 billion by 2028, according to a recent report.
While still in its infancy, recent research shows the combination of AI and wearables can accurately detect early SARS-CoV-2 infection.
The agency needs a plan on use of EUA authority to get lab tests to market during the next public health emergency, says the GAO.