COVID-19-Related EUAs Bolster Record Number Of Novel Devices Greenlit By FDA

According to top FDA officials Jeff Shuren and William Maisel, regulators approved, cleared and authorized 132 novel devices up from its previous record of 106. It’s in large part due to EUAs for novel COVID-19 products issued last year.

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 said the agency greenlit a record number of novel devices in 2020 • Source: US FDA

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