Bloomberg Law
May 19, 2021, 8:40 PM

Covid Device Makers to Get FDA Guidance on Seeking Full Approval

Jeannie Baumann
Jeannie Baumann

Device makers will have guidance this year from the FDA on how to move their Covid-19 products from temporary authorization to full approval, the agency’s device head said.

The Food and Drug Administration is working on two draft guidance documents—one focusing on new devices and the other on existing ones that have been modified for Covid patients, Jeffrey E. Shuren, director of the agency’s Center for Devices and Radiological Health, said Wednesday.

More than 1,300 medical devices and more than 370 tests for Covid-19 have come on the market under an emergency use authorization, Shuren said at the Food and ...

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