US FDA Device Center Hopes For ‘Normal Operations’ In 2022
Some device center functions should be back to user-fee timelines next year, but delays will persist in the divisions hardest hit by COVID-19, a blog post by top agency officials says.
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Top US FDA device center officials Jeff Shuren and William Maisel said in a 15 April blog post that manufacturers should expect a delay in the review of new product submissions thanks to the pandemic. They noted that the agency also won’t be accepting certain IVD pre-submission requests until next year.
US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt – to the COVID-19 pandemic when it comes to medical device and diagnostic regulation.