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US FDA Device Center Hopes For ‘Normal Operations’ In 2022

 
• By Elizabeth Orr

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.

FDA's Jeff Shuren (left) and William Maisel (right) said the agency greenlit a record number of novel devices in 2020.
FDA's Jeff Shuren (left) and William Maisel (right) discussed the device center's goals for getting back to pre-pandemic operations in 2022. • Source: US FDA

It’s no secret that the ongoing coronavirus pandemic has brought a greatly increased workload to the device center at the US Food and Drug Administration. But in a 21 December end-of-year blog post, two top officials at the Center for Devices and Radiological Health (CDRH) disclosed plans for transitioning to something closer to “normal” in 2022.

The CDRH has granted 1,900 emergency use authorizations (EUAs) over the course of the pandemic, center director Jeff Shuren and Office of Product Evaluation and Quality director William Maisel wrote – fifteen times as many as during all prior public-health emergencies combined

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