De novo device clearances fall out of fashion

De novo device clearances fall out of fashion

Source: 
EP Vantage
snippet: 

The number of de novo clearances – the route by which low-risk novel devices reach market – which has exploded in popularity in recent years, has fallen sharply. True, this trend could reverse in the second half of 2019, but it does prompt questions about whether the FDA can achieve its aims of speeding up approvals of low-risk devices.