To say that 2020 was a challenging year for FDA would be an understatement. The COVID-19 pandemic stretched resources thin as it grappled with unprecedented regulatory demands as a result of the U.S. public health emergency.
FDA’s response to the coronavirus crisis focused on increasing availability of testing, therapeutics and vaccines, as well as medical devices such as ventilators and personal protective equipment.
Despite these challenges, FDA in 2020 approved, cleared or authorized a record 132 novel medical devices, topping the 106 novel device authorizations in 2018 that marked a 40-year high.
