The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total.
That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH).
Novel devices include those brought to market through the premarket approval (PMA), humanitarian device exemption (HDE) and de novo pathways, as well as a subset of those that gain 510(k) clearance or an EUA.
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