ARTICLE SUMMARY:
CDRH identified 41 COVID-19 authorizations that it categorizes as “novel” devices, but even without those non-COVID-19 novel device approvals and clearances jumped back up in 2020 after a drop in 2019.
For the full interview with CDRH Director Jeff Shuren, see “Jeff Shuren on Novel Devices, MDUFA Talks, and the Toils of COVID,” Market Pathways, February 5, 2021.
It is no secret that FDA’s device center had a record-setting year in 2020 when it comes to the more than 600 COVID-19 Emergency Use Authorizations it granted, but 2020 also turned out to be a solid year for non-COVID novel devices despite the distractions, according to numbers supplied to Market Pathways by CDRH.
