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.

Approved stamp
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[Editor's note: For sortable and searchable tables of all US and non-US approvals and clearances in 2019 and previous years, check out our Approvals Tracker. For comprehensive tracking of company events and catalysts related to approvals and clearances, go to Meddevicetracker. Not a subscriber? Click here to request your free demo.]

After four straight years of steady increases, the number of novel medical devices approved by the US Food and Drug Administration declined in 2019 compared to 2018.

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