FDA Week - 06/26/2020

Device Makers Want FDA To Preview Post-Pandemic Flexibility Plans

By Kelly Lienhard / June 23, 2020 at 4:19 PM
Medical device manufacturers are urging FDA to release guidance detailing the agency’s expectations for products released under emergency use authorizations (EUAs) and emergency discretion guidances once the COVID-19 public health emergency comes to a close and the temporary approvals are suspended. The number of devices currently on the market under temporary authorizations is unprecedented and the industry is unable to craft future business plans without clear expectations from the agency, sources say. Yarmela Pavlovic, a partner at Manatt Health, told...

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