FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

The Fda is proposing that it give health-related system makers about 50 percent a year’s observe just before terminating emergency use authorizations write-up-pandemic.

That was just one of the main takeaways from the draft guidance that the Fda unveiled today. It considers techniques to transition clinical gadget regulation when COVID-19 moves from a pandemic to an endemic phase. There are presently hundreds of professional medical devices marketed in the U.S. under EUAs issued during the pandemic.

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