ARTICLE SUMMARY:
The pandemic experience will be a major factor in upcoming user fee talks and in a diagnostics regulatory reform debate that continues to escalate.
The COVID-19 pandemic is all at once presenting a massive challenge to FDA’s workload capacity in the diagnostics space and placing a big spotlight on the instabilities in the US diagnostics oversight framework. As a result, FDA’s ever-evolving approach to the COVID-19 testing challenge will be a key driver in several upcoming Washington, DC, debates in the medtech sector, particularly around agency resources and diagnostics regulatory reform.
