The U.S. Food and Drug Administration has committed to create a plan for how medical devices distributed during the COVID-19 public health emergency will transition to the market after the pandemic ends.
In a Bloomberg Law article, life sciences regulatory and compliance partner and chair Greg Levine (Washington, D.C.) explains that for COVID-19 tests, developers have to meet certain efficacy thresholds. At least one of those tests will need to get permanent marketing authorization through the FDA’s novel device regulatory pathway.
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