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FDA authorized its first De Novo in the Trump era. Excerpted from Pathways’ Picks March 26: MDR Reform Input Streams In, Makary Confirmed at FDA, and More.
FDA authorized Nanosonics’ Coris cleaning platform for flexible endoscopes via the De Novo route March 19. It’s of course an important milestone for the Australian company, but the decision also caught the notice of regulatory experts for another reason: It’s the first De Novo granted by FDA in two months and the first since President Trump took office. Because of the unique nature of the De Novo program as a mechanism to establish new device categories in the Code of Federal Regulations, experts have feared the pathway could be jammed up by Trump’s January 31 executive order mandating agencies to repeal 10 regulations for one new item. The Coris authorization offers some reassurance, but more time and data are needed to be sure about the fate of devices pursuing the De Novo route in the coming months and years, experts tell Market Pathways (look out for more details on this topic shortly).