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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Senseonics Projects Slow Growth In 2022 Despite FDA Approval Of Eversense E3 CGM
Senseonics announced the long-awaited FDA approval of its Eversense E3 implantable CGM, featuring a sensor that lasts up to six months. The company is also developing a one-year version of Eversense and a transmitter-less version, but the stock market is disappointed with its sales projections.
Submitting A Non-COVID-19 Product For FDA Review? Then Take A Seat, It’s Gonna Be Awhile
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.
COVID-19 And FDA: Official Tells How Pandemic Has Affected Agency’s Regulatory Work
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.