FDA Issues New Guidelines for COVID-19 Test Kits

The Food and Drug Administration (FDA) has updated the list of approved COVID-19 test kits to include self-administered test kits with Special Certification. This certification is an FDA authorization issued to companies that wish to distribute COVID-19 Test Kits.

The new guidelines are intended to ensure that self-administered test kits are accurate and reliable. In order to obtain Special Certification, companies must submit data to the FDA demonstrating that their test kits meet certain performance criteria. These criteria include sensitivity, specificity, and accuracy.

The FDA's decision to update the list of approved COVID-19 test kits is a significant step forward in the fight against the pandemic. Self-administered test kits can help to increase access to testing, which is essential for identifying and isolating infected individuals. The FDA's new guidelines will help to ensure that self-administered test kits are accurate and reliable, so that people can trust the results.