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CDRH’s Shuren Calls For ‘Reset’ Of FDA Medtech Initiatives

Programs disrupted by COVID-19 would be restarted in 2021 to guide developers on clinical decision support software, produce safe OTC hearing aids

 
• By Sue Darcey

US FDA device center director Jeff Shuren wants to hit the reset button for initiatives delayed by agency’s responses to the coronavirus pandemic.

Reset after COVID-19

A series of important initiatives planned by the US Food and Drug Administration’s device center for 2020, but delayed by the center’s need to clear and approve tests and equipment vital to fighting the coronavirus, will be carried out in 2021, center director Jeff Shuren says.

Shuren pointed out that more than 600 devices – half of them diagnostics – received emergency use authorization approval this year. At the same time, the FDA continued to receive...

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