ARTICLE SUMMARY:
FDA authorized a novel tool for cleaning flexible endoscopes March 19, providing some assurance that the De Novo classification pathway won’t be completely restrained by the Trump administration’s “10-to-1” deregulation order. But questions remain about the specific impacts of that policy and other challenges facing the agency on De Novos and the broader device review process.
FDA authorized Nanosonics’ Coris cleaning platform for flexible endoscopes via the De Novo route March 19. It’s an important milestone for the Australian company and for prevention of hospital-acquired infections. 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. The authorization is a promising though not conclusive sign that this novel device premarket pathway will be able to function under the administration’s strict “deregulatory” agenda.
“It's encouraging to see the first De Novo come through the pipeline, to come out the other side,” said Philip Desjardins, a partner in Arnold & Porter’s Life Sciences & Healthcare Regulatory practice and former CDRH and device industry official. “I think a week ago we were all twiddling our thumbs, waiting to see, 'was there a complete pause on all De Novo classification orders coming forward?' We know that's at least not the case.”
But more evidence is needed to understand whether the regulatory pathway will be able to function relatively normally—perhaps hindered to some extent by staffing shortages—after a typical post-election transition, or whether it will be more specifically restrained by President Trump’s January 31 executive order requiring agencies to repeal 10 regulations for every one new item, the attorney suggested.
