2019 Device Approvals Review: Original PMAs Up, De Novos Down
The US FDA approved fewer novel devices in 2019 than in 2018, despite a slight increase in original PMA approvals. De novo clearances were down significantly after four straight years of increases, while panel-track PMA supplements and 510(k) clearances also declined from the 2018 totals.
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It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.
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