COVID Testing Conundrum Feeds FDA Resource, Reform Debates

article image

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.


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: