In The News

In Bloomberg Law, Greg Levine Evaluates FDA Plans for Permanent COVID-19 Test Authorization

Practices: Life Sciences, FDA Regulatory, Health Care, Technology, Media & Telecommunications

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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