Coronavirus Mutations: FDA Singles Out 4 Molecular Tests That Can Give False Readings
The US FDA says it’s concerned that virus mutations could lead to false results with certain COVID-19 tests and lists tests it has found are prone to lower sensitivity, based on the agency’s own analysis.
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The US agency’s immediately-in-effect guidance document – released on 22 February – explains how makers of COVID-19 diagnostics can assess whether their tests are impacted by mutations of the virus.
The US agency published a final rule on 16 April that says eight medical software functions will no longer be classified as medical devices. The rule finalizes a statutory provision from the 21st Century Cures Act.
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.